Clinical Trials

New study uses cryoablation to reduce pain for cancer patients

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Kevin Makowski, RBP

A new study using cryoablation to decrease pain for patients who have cancer metastases in the bone is now underway throughout Emory Healthcare. Cryoablation is a process that uses extreme cold (cryo) to destroy or damage tissue (ablation).

Called the “Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases”, or MOTION, the study aims to assess the effectiveness and safety of cryoablation therapy to treat patients with painful bone metastases and document the effects the procedure has on their condition.

The prospective, single-arm study will enroll 60 participants at eight centers in the U.S. and internationally. Twenty participants can enroll at Emory Johns Creek Hospital, Emory University Hospital, Emory University Hospital Midtown, and Emory Saint Joseph’s Hospital. Participants will serve as their own control group in this one-year study.

The clinical trial examines self-reported pain scores from the patients. Investigators are assessing improvement in scores defined by more than a two-point reduction in the worst pain in the last 24 hours, using the Brief Pain Inventory (BPI), from before the cryoablation procedure to eight weeks after the procedure takes place. The trial will assess patients experiencing pain at a level of 4 or above on a scale of 0 (no pain) to 10 (unimaginable pain).

The goal is to freeze cancerous cells and stop the pain signals to the brain. We use image guidance to insert the ablation probe into the middle of a painful cancer lesion. Then, we create an ablation zone by lowering the temperature to minus 40 degrees centigrade for 10 minutes.

Emory interventional radiologists freeze tumors in order to kill cancer cells in contact with the bone and reduce the size of the tumor. CT images obtained during the procedure helps doctors guide needles into the tumor.

Cryoablation provides an alternative for patients who haven’t experienced relief from current pain therapies. Many patients suffering from cancer pain take several medications to cope with the pain.

The outpatient cryoablation procedure takes about an hour.

Galil Medical is funding this clinical trial.

For more information about this study, contact the study coordinator, Maria Rivas at 404-712-7962.

Learn more about other available trials.  http://clinicaltrials.emory.edu/

Dr. J. David Prologo

J. David Prologo, MDdavid_prologo_photo, is an assistant professor in the Department of Radiology and Imaging Sciences at Emory’s School of Medicine, and director of Interventional Radiology Services at EJCH. Prologo is the principal site investigator for the MOTION study, and one of 10 subspecialty trained, board certified interventional radiologists at Emory.

Healthy Participant Raises Awareness for Importance of Clinical Trials

cmv_brittanyBrittany Robinson of Suwanee, GA, recently spent eight days and nights at Emory University Hospital, but she was not sick. To some people, spending over a week away from her husband and five children may seem crazy, but for Brittany, it was a personal way to give back and say thank you to the hospital that helped her son, Ethan.

Ethan was diagnosed at birth with the heart defect Wolff-Parkinson-White (WPW) syndrome with Ebstein’s anomaly, and was treated at Emory-Children’s Center. “My son was on medication from nine months old until last year. If there wasn’t someone doing this for him, for his heart medication, who knows what would have happened,” said Robinson. The medicine prescribed to Ethan went through the same process rigorous clinical trials process that all new drugs must go through.

It was this realization that prompted Brittany to enroll in an in-patient research study (A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of MBX-400 in Healthy Volunteers), testing the oral medication MBX-400 to treat cytomegalovirus (CMV) infection.

CMV is a common virus that can infect the majority of the population but can cause severe eye, neurologic, and organ diseases in patients with a weakened immune system. The oral and IV medications currently used to treat CMV have limitations and many scientists are stepping up to help find a new treatment. The study’s enrollment criteria requires only healthy people can enroll.

Allison Beck, PA, Mari Hart, RN, Nadine Rouphael, MD, and a team of Research Coordinators with the Hope Clinic have been recruiting for months to fully enroll this trial. Their struggle is common for clinical trial recruitment. People are hesitant because they do not want to be a “guinea pig” or are too busy to interrupt their normal routine though most studies provide compensation for time and travel. Unfortunately, people like Brittany who’ve relied on the medical field to save their loved ones usually do not make the incredible connection she made. This study is still enrolling and only has half the participants needed to complete the trial.

“Without research, we do not have the treatments and cures that save our loved ones. New medicines and vaccines that work and are safe are only discovered when heroes like Brittany and her family are willing to give their time to research and enroll in a study,” said study PI Mark Mulligan, MD, distinguished professor, Department of Medicine and executive director, Hope Clinic of the Emory Vaccine Center, Emory University. While Brittany may never know anyone with CMV, she is helping to give better treatments to those who are ill.

Every medication, treatment, or medical device currently available was FDA mandated to go through this process to prove safety and efficacy. This pipeline of new treatments and cures stops if trials cannot find participants. Clinical trials close and treatments and cures never make it to those who are ill.

After eight days at Emory University Hospital, Robinson says she feels better than ever and is more in-touch with her overall health. “The experience has been wonderful. I was actually very nervous going into it. I’ve never been away from my family for this long before. But I feel better, because you have to do a fast, can have no alcohol or caffeine, and I’ve actually gotten sleep. I feel refreshed, like a paid vacation,” said Robinson. The in-patient trial provides all meals, a room with a view, and the quiet needed for adequate rest. Something Robinson says she has not had since her first son was born eight years ago.

The Emory Hope Clinic needs more volunteer participants for this study and others. More information is available at www.hopeclinic.emory.edu and by calling 404-712-1371. The study is conducted by Emory’s Vaccine and Treatment Evaluation Unit (VTEU) funded by the U.S. National Institutes of Health (NIH).

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Read Brittany’s full story here
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Clinical Trials at Emory

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New Website Makes Searching For Emory Clinical Trials Easier

cthp-250x250We are thrilled to announce the launch of a new Emory clinical trials website! The new site – clinicaltrials.emory.edu – features easy-to-access information for nearly 1,000 active clinical trials at Emory that are currently seeking volunteers.

Potential clinical trial participants may easily search for trials related to a specific health condition or browse by topic areas such as cardiology, cancer, or neurosciences and view quick facts about each of the individual trials. While many clinical trials are seeking patients who have a particular disease, many others are seeking healthy volunteers.

“Emory’s ability to develop improved therapies through clinical research is a key component of our clinical mission and gives patients access to the most advanced treatments available,” says Jeffrey Lennox, MD, associate dean for clinical research in Emory University School of Medicine. “This new clinical trials website will allow more people within Emory and the broader community to learn about and participate in the wide range of available clinical trials.”

What Information Is Included On The New Website?

Each clinical trial listing includes information on its purpose, timing, key investigators, process, and eligibility criteria. For additional information, potential volunteers may click on a link to send a message the leader of each individual trial. Emory trials will continue to be listed in the National Institutes of Health (NIH) clinical trials database – clinicaltrials.gov– which provides more detailed information.

If you wish to learn more about clinical trials in general, the new website also includes frequently asked questions about volunteering, information on additional resources at Emory for potential participants, and NIH information about clinical trials.

The Value Of Clinical Trials

Medical advances and improvements to clinical care have been made possible the participation of volunteers in clinical trials. Some studies test new drugs or surgical procedures and devices, while others look for better ways to prevent diseases in people who have either never had a disease or are trying to prevent one from coming back. Other types of trials help find ways to improve the care and quality of life of people with long-term illnesses and diseases.

People choose to participate in clinical trials for a variety of reasons. Current patients may participate in order to receive care and potentially benefit from a new therapy. Healthy volunteers may participate in clinical trials to help current and future patients and to contribute to help researchers find better treatments.

For more information on clinical trials at Emory, please ask your Emory physician or call the Emory HealthConnection℠ at 404-778-7777.

 

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Emory-led clinical trial tests microneedle skin patches as alternative to flu shot

An example of a microneedle patch. Photo by Gary Meek, gatech.edu

An example of a microneedle patch. Photo by Gary Meek, gatech.edu

A clinical trial at Emory University is currently underway to test whether microneedle patches applied to the skin are a safe and effective alternative to conventional flu shots.

The patches, which are about the size of a quarter, contain very tiny (thin and short) needles, called microneedles, which are barely visible to the eye. Once the patch is applied to the skin, the microneedles begin to penetrate the upper layers of the skin and deliver the vaccine.

Researchers plan to enroll up to 100 participants in the clinical study conducted at the Hope Clinic of the Emory Vaccine Center. Volunteers must be healthy adults between ages 18 and 49 who did not receive a flu shot in the 2014-2015 season will receive either one dose of the regular flu shot or one patch containing either the flu vaccine or containing placebo.

The flu vaccine used in the study is the same as the FDA-approved flu vaccine from last season. The purpose of the study is to assess the safety of the microneedle patch, how the body’s immune system responds to the vaccine delivered through a patch, and participants’ opinions about using the patch. Participants will receive follow up, including blood work, during six visits over six months.

For more information about the microneedle clinical study, contact the Hope Clinic by phone at 404-712-1371, email at vaccine@emory.edu or click here.

For more information about clinical trials at Emory Healthcare, visit our clinical trials website and make sure to review the list of frequently asked questions.

Breakthrough clinical study exposes crucial role parents play in behavior management for children with autism

parent-childHighlighted in an April issue of the Journal of the American Medical Association, a clinical trial involving Emory University and the Marcus Autism Center provided insight into the effect parent training has on managing disruptive behavior with young children with autism spectrum disorder (ASD) and serious behavioral problems.

ASD is a chronic condition beginning in early childhood and is mostly characterized by impaired social communication and repetitive behavior. Commonly, severe behavioral problems accompany ASD in young children including tantrums, aggression, self-injury and severe noncompliance in response to routine environmental demands. For parents of children with ASD, these disruptive behaviors can be overwhelming and produce uncertainty on how to handle these problems. While there are approved medications for these disruptive behavioral problems, many parents are often reluctant to use medication.

In the multi-location study, 180 children (age 3 to 7 years) with ASD and serious behavioral problems were randomly assigned to either 24 weeks of parent training or 24 weeks of parent education. The study aimed to measure the effect of parent training in managing disruptive behaviors versus basic parent education. The following provides more detail on the difference between the two groups:

  • Parent training provided parents with specific/ practical skills and techniques for how to manage serious behavioral problems.
  • Parent education offered useful information on autism – but did not provide guidance on how to manage serious behavioral problems.

Study results were documented by both parents of the participating children, as well a clinician who was blind to treatment assignment:

  • Parent ratings: after 24 weeks of treatment, children in the parent-training group showed a 48 percent improvement on disruptive behavior compared to a 32 percent decline for parent education.
  • Clinician ratings: at week 24, 70 percent of children in the parent-training group showed a positive response, compared to 40 percent for parent education.

“This is the largest randomized trial of any behavioral intervention in children with autism spectrum disorder, and it shows that parent training works,” notes Lawrence Scahill, MSN, PhD, professor of pediatrics at Marcus and Emory School of Medicine, who directed the study.

Overall study results: while children in both groups improved, parent training was more effective in reducing disruptive and aggressive behavior than parent education. In fact, the benefits of parent training continued for up to six months after the clinical trial, demonstrating the benefits of parent training last over time.

Despite the increased methods for recognizing ASD in young children, rigorous testing and the distribution of evidenced-based treatments have lagged. Using the results of this study, researchers and physicians are able to show the impact of parent training and disseminate learned practices to a wider population.

To find an autism-related clinical trial at Emory, click the “Search for a clinical trial at Emory” link and type in the terms “Autism” and “Emory” into the search field.

Revolutionary Research Underway with First-in-Man Clinical Trial for Hunter Syndrome

Hunter SyndromeAs an academic medical center, many physicians at Emory not only take care of patients on a daily basis, but also partake in research and teaching/training the future generations of physicians.

It’s through discovery that happens during clinical trials and research that allows for new advancements in medicine to be made. Providing the standard of care of is not always enough. New treatment therapies, technology and care delivery techniques must be developed, tested and perfected in order to keep advancing health care.

Not sure what clinical trials are? Check out our blog post that explains Clinical Trails>>

 
Currently happening at Emory is the first-in-man clinical trial, testing a newly developed drug for a rare genetic condition called mucopolysaccharidosis type II (MPS II) or Hunter syndrome.

Hunter syndrome is a hereditary disease in which a critical enzyme is either missing, or there is not enough of it. Without enough of this enzyme, long chains of sugar molecules do not break down properly in the body and accumulate in the organs and tissues and become toxic.

To treat most cases of Hunter syndrome, an enzyme replacement medication is used, but this regimen does not cross into the brain to treat the most severe cases of Hunter syndrome. In this particular trial, Emory researchers are testing whether a man-made enzyme fused with an antibody and injected into the bloodstream will deliver the enzyme therapy into the brain. This is the first time this medication combination has been tested in a human.

The video below features Emory patient, Chris Dutcher. “By testing this new medication for the first time in a human, my hope is to help children with severe Hunter syndrome,” says Dutcher, whose younger brother also has the same disorder.

Chris has the mild version of Hunter syndrome, but his symptoms are still quite serious and involve the lining of the brain and spinal cord, which are not treated by existing medications. He is the first patient to receive the new treatment therapy.

More information about Hunter syndrome and this clinical trial can be found in the Emory News Center. Learn more about clinical trials at Emory Healthcare.

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Understanding Clinical Trials – Part 4: What Questions Should You Ask Before Enrolling in a Clinical Trial?

Clinical Trials QuestionsParticipation in clinical trials is 100% voluntary. While there are many benefits to participating in clinical trials, there can also be risks. If you have been offered a clinical trial, or are considering participating, it is important to talk with your physician before enrolling in one. Your health care team wants to make sure you have all the information needed to make a decision.

Do not hesitate to ask any questions or bring up any issues concerning the trial with the research team associated with the clinical trial. Tips for asking about clinical trials include:

  • Take a family member or caregiver with you for support and for help in asking questions and recording answers.
  • Plan questions ahead of time — you can still ask new questions you think of while you’re there, but it helps to be prepared ahead of time.
  • Write down your questions in advance, to make sure you remember to ask them all.
  • Write down the answers, so that you can review them whenever you want.

The National Institutes of Health (NIH) developed a list of suggestions that may be helpful to review as you think about the questions you may have:

Questions about the Study

  • What is the purpose?
  • Why do researchers think the approach may be effective?
  • Who will fund the study?
  • Who has reviewed and approved the study?
  • How are study results and safety of participants being checked?
  • How long will the study last?
  • What will my responsibilities be if I participate?

Questions about Possible Risks/Benefits

  • What are my possible short-term benefits?
  • What are my possible long-term benefits?
  • What are my short-term risks, such as side effects?
  • What are my possible long-term risks?
  • What other options do people with my disease have?
  • How do the possible risks and benefits of this trial compare with those options?

Questions about Participation and Care

  • What kinds of therapies, procedures and /or tests will I have during the trial?
  • Will they hurt, and if so, for how long?
  • How do the tests in the study compare with those I would have outside of the trial?
  • Will I be able to take my regular medications while in the clinical trial?
  • Where will I have my medical care?
  • Who will be in charge of my care?

Questions about Personal Health Issues

  • How could being in this study affect my daily life?
  • Can I talk to other people in the study?

Questions about Financial Issues

  • Will I have to pay for any part of the trial such as tests or the study drug?
  • If so, what will the charges likely be?
  • What is my health insurance likely to cover?
  • Who can help answer any questions from my insurance company or health plan?
  • Will there be any travel or child care costs that I need to consider while I am in the trial?

At Emory Healthcare, our physicians and researchers want to answer all your questions about clinical trials and research. View some of our frequently asked questions, or hear from our patients who have gone through clinical trials.

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Understanding Clinical Trials – Part 3: What are the Phases of Clinical Trials?

Phases of Clinical TrialsThe goal of clinical trials is to determine if new treatments, drugs and care-delivery processes are safe and effective. Discovery and data collected from clinical research studies impacts patient care, here and now, while also informing future generations with the hope of achieving better outcomes. But clinical studies do not happen overnight, and in fact, some take years to yield enough information to answer specific questions they are designed to answer.

Clinical trials take place in “phases,” and each phase helps researchers answer specific questions. Learn more about the different phases of clinical trials below:

Phase I:

These trials are used to test brand new drugs, devices or procedures to find out how safe they are, including safest dose, and identify possible side effects. They usually involve 20 to 80 people.

Phase II:

These trials are used to further evaluate the effectiveness of a drug, device or procedure. The researchers keep track of any medical benefits, as well as side effects. They usually involve 100 to 300 people. At the end of Phase II trials, the U.S. Food and Drug Administration (FDA) and trial sponsors determine how Phase III trials will be conducted.

Phase III:

These trials compare a new treatment or procedure to current treatments to figure out which works better. Safety and level of effectiveness continued to be monitored, as well as side effects. They usually involve 1,000 to 8,000 people.

Phase IV:

Once a drug or procedure is approved by the FDA and made available to the public, researchers continue to study its safety to figure out the best use of the new treatment. Information is gathered on the drug’s long-term effectiveness in various populations, as well as adverse side effects associated with long-term use. In the video below, Dr. Donald Harvey walks through the different phases of cancer-specific clinical trials.

Related Resources

Understanding Clinical Trials – Part 2: What are the Benefits of Clinical Trials?

With any clinical trial, there are both benefits and risks associated; however, clinical trials are not just for sick people, unlike common perception. Both healthy people and people with certain diseases or conditions participate in clinical trials. While some participate to receive care or treatment only available through a clinical trial, others participate to help researchers find better treatments.

For researchers, physicians and health care professionals, clinical trials are extremely important because they allow us to make real-time differences in medicine. Treatment regimens, drugs and care-delivery protocols all exist today because of clinical studies conducted in the past. Clinical trials and research provide not only hope for our patients, but a possibility for better outcomes and medical advancements in the future.

As a leading academic medical center, Emory Healthcare is proud to offer more than 1,000 clinical trials to our patients. Some direct benefits patients receive by participating in clinical trials include:

  • Access to new treatments that are not yet available to the general public
  • Access to more effective treatments than the standard care therapies
  • Close oversight from medical experts at a leading health care facility in the Southeast
  • Helping others by contributing to medical research

The decision to participate in a clinical trial is completely voluntary; therefore, to help you and your loved ones decide whether or not to participate, it is important to understand any potential risks. The known risks and benefits are different depending on the clinical trial, so make sure you talk to members of the research team before making a decision.

In the video below, Emory researchers and doctors discuss the benefits of clinical trials.

Related Resources

Learn More About Clinical Trials at Emory Healthcare
Find a Clinical Trial at Emory

Is Insomnia Linked to High Blood Pressure?

insomnia clinical trialWith more than 1,000 clinical trials underway at Emory, today’s research is giving patients and families a better tomorrow. Read about one of our active nursing clinical trials below:

Hypertension, or high blood pressure, is a common but serious condition. According to the Centers for Disease Control and Prevention, about 1 in every 3 adults in the United States (about 70 million people) has high blood pressure.

Having high blood pressure means the pressure of blood in the blood vessels is higher than it should be, which can be a risk factor for heart disease and stroke, two of the leading causes of death for Americans.

While hypertension can be controlled through prescribed medications, lifestyle changes are equally as important. A healthy diet and exercise are known ways to lower blood pressure, but a clinical trial currently underway at the Nell Hodgson Woodruff School of Nursing at Emory University is investigating whether adequate sleep also helps reduce high blood pressure.

Insomnia – or trouble getting to sleep, staying asleep or early morning awakenings – is a very common sleep disorder associated with decreased quality of life, reduced work productivity and increased health care costs. In recent years, insomnia has also been associated with hypertension and cardiovascular disease.

In this particular study, funded by the American Heart Association, participants participate in an online sleep improvement program once a week for six weeks. The goal of the trial is to determine if the program is effective in lowering blood pressure and improving sleep, mood and cognition in people with insomnia and high blood pressure.

Do you have high blood pressure? Do you have trouble sleeping? Eligible participants will receive compensation for their time and effort. For more information, click to view the informational flyer for this trial>>

Related Resources

Find an Emory trial
Clinical Trials – FAQs
Understanding Clinical Trials – Part 1: What are Clinical Trials?
Emory School of Nursing