Current Clinical Trials
We currently are recruiting patients for the following clinical trials:
Radioimmunoimaging of AL Amyloidosis:
The ability to visualize a disease process by CT, PET, or MRI scans provides physicians with an important diagnostic tool, as well as a means to tell if a patient is responding to treatment. In the case of AL (primary) amyloidosis, these techniques are not particularly informative or “amyloid-specific.” Given the need to document the presence and amount of amyloid in major organs, such as the heart, liver, spleen, and kidneys, we are utilizing another strategy; namely, one that is based on our experimental data that have shown that an antibody developed in my laboratory, when labeled with a particular isotope of iodine, can interact with the amyloid, causing it to “light up” when scanned by PET/CT. These findings have led us to initiate an FDA-sponsored trial designed to determine how effective this antibody will be as an amyloid imaging agent. We now are recruiting patients for the study which involves an infusion of the radiolabeled antibody over 10-20 minutes, followed in 48 hours by a 40-minute PET/CT scan which is repeated three days later. To be eligible, individuals must have a confirmed diagnosis of AL amyloidosis and not be on kidney dialysis. There is no charge to participate, except for routine laboratory and other tests, which typically are covered by insurance. For those who live out of town, limited funds are available to cover the cost of transportation, food, and housing.
Human Immune Globulin in Treating Patients with Primary Amyloidosis that is Causing Heart Dysfunction:
Patients with AL amyloidosis who have predominant heart involvement unfortunately have a poor prognosis. In this regard, we have found that human immune globulin (an FDA-approved protein product) contains naturally occurring anti-amyloid antibodies and we have shown experimentally that they are capable of eliminating amyloid deposits. Based on these findings, we are conducting a drug company-sponsored trial to determine if human immune globulin indeed can be of benefit to those with heart-related AL amyloidosis. Eligible participants will be given intravenous infusions of this protein (this takes approximately 2 hours) in my clinic once a week for three months and then at two-week intervals during the next 9 months. Although there is no cost for the human immunoglobulin product, patients are responsible for routine clinic and laboratory charges, which typically are covered by insurance.
For more information, please contact us.
The University of Tennessee Graduate School of Medicine
Office of the Dean
1924 Alcoa Highway, U94
Knoxville, TN 37920
Phone: (865) -305-9290 or
(800)-596-7249
Fax: (865) 305-6819