- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00958997
Positron Emission Tomography (PET) Imaging of Pancreatic Beta-Cell Mass in Healthy and Type 1 Diabetic Patients
July 20, 2012 updated by: Gary Cline, Yale University
Quantitative PET Imaging of Pancreatic Beta-cell Mass in Healthy and Type 1 Diabetic Patients With 18F-FP-DTBZ (AV-133)
Pancreatic Islet beta-cells are responsible for synthesizing and secreting appropriate amounts of insulin to regulate blood glucose levels.
One factor in the development of diabetes is the loss of beta-cells.
Developing treatments to prevent or restore islet beta-cell mass (BCM) in diabetic patients is hampered by a lack of methods for the non-invasive imaging of these cells.
This study is designed to evaluate a radiolabeled compound that binds to the pancreatic islet.
The investigators will test the ability of one promising imaging compound, 18F-9-fluoropropyl-(+)-dihydrotetrabenazine (18F-FP-DTBZ), to measure the amount of pancreatic islet beta-cells in patients with long-standing type-1 diabetes and in age-weight-matched healthy control subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University School of Medicine, PET Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community Sample
Description
Inclusion Criteria:
Patients with Type 1 diabetes may be enrolled if they meet all of the following criteria:
- Have a diagnosis of Type 1 diabetes mellitus defined by ADA criteria or judgment of physician; diabetes onset younger than age 18, duration >5 years
- Have fasting C-Peptide ≤ 0.1 ng/ml
- BMI between 18 and 29 kg/m2
- Able to tolerate PET and MR imaging
- No metal implants
- No claustrophobia
Healthy volunteers may be enrolled if they meeting all of the following criteria:
- Have no history of Type 1 diabetes
- Fasting blood glucose ≤ 100 mg/dL
- Negative islet autoantibody testing
- BMI between 18 and 29 kg/m2
- Able to tolerate PET and MR imaging
- No history of previous allergic reactions to drugs
- No metal implants
- No claustrophobia
Exclusion Criteria:
- Clinically significant renal dysfunction;
- Clinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (AST, ALT, Total/Direct Bilirubin, Alkaline Phosphatase);
- Coagulopathy;
- History of allergic reactions to any drug
- Current use of any medications except for insulin for Type 1 diabetes
- Clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (including but not limited to QTc>450 msec);
- Clinically significant psychiatric disease; Clinically significant pulmonary, renal or hepatic impairment or cancer, have clinically significant infectious disease, including AIDS or HIV infection, or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2; subjects will be asked about this. No testing will be performed.
- Have a history of alcohol or substance abuse or dependence;
- Are women of childbearing potential not refraining from sexual activity or not using adequate contraception. Women must not be pregnant (negative serum β-HCG at the time of screen) or lactating at screening, and must agree to take appropriate steps not to become pregnant during the study and for 30 days following the study.
- Currently receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days.
- Have received a diagnostic or therapeutic radiopharmaceutical within 7 days prior to participation in this study.
- Claustrophobia
- Metal implants (pace-maker, artificial joints, non-removable body piercings)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type 1 diabetic subjects
Patients with Type 1 diabetes who have a diagnosis of Type 1 diabetes mellitus defined by ADA criteria or judgment of physician
|
The subjects will receive a single IV bolus of approximately 10 mCi 18F-AV-133.(Injection will contain no more than 25 µg of non-radiolabeled 19F-AV-133).
A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.
|
Healthy control subjects
Age-weight-BMI matched to the subjects with type-1 diabetes
|
The subjects will receive a single IV bolus of approximately 10 mCi 18F-AV-133.(Injection will contain no more than 25 µg of non-radiolabeled 19F-AV-133).
A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PET-determined pancreatic islet beta-cell mass
Time Frame: 150 minutes post-dose of imaging agent
|
150 minutes post-dose of imaging agent
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin secretion response following an acute arginine-stimulus test
Time Frame: Six minutes following administration of arginine challange
|
Six minutes following administration of arginine challange
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gary W Cline, Ph.D., Yale School of Medicine
- Study Director: Yu-Shin Ding, Ph.D., Yale School of Medicine
- Study Director: Kitt F Petersen, M.D., Yale School of Medicine
- Study Director: Richard Carson, Ph.D., Yale School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Larsson H, Ahren B. Glucose-dependent arginine stimulation test for characterization of islet function: studies on reproducibility and priming effect of arginine. Diabetologia. 1998 Jul;41(7):772-7. doi: 10.1007/s001250050986.
- Goswami R, Ponde DE, Kung MP, Hou C, Kilbourn MR, Kung HF. Fluoroalkyl derivatives of dihydrotetrabenazine as positron emission tomography imaging agents targeting vesicular monoamine transporters. Nucl Med Biol. 2006 Aug;33(6):685-94. doi: 10.1016/j.nucmedbio.2006.05.006.
- Kilbourn MR, Hockley B, Lee L, Hou C, Goswami R, Ponde DE, Kung MP, Kung HF. Pharmacokinetics of [(18)F]fluoroalkyl derivatives of dihydrotetrabenazine in rat and monkey brain. Nucl Med Biol. 2007 Apr;34(3):233-7. doi: 10.1016/j.nucmedbio.2007.01.007.
- Kung MP, Hou C, Goswami R, Ponde DE, Kilbourn MR, Kung HF. Characterization of optically resolved 9-fluoropropyl-dihydrotetrabenazine as a potential PET imaging agent targeting vesicular monoamine transporters. Nucl Med Biol. 2007 Apr;34(3):239-46. doi: 10.1016/j.nucmedbio.2006.12.005.
- Kung MP, Hou C, Lieberman BP, Oya S, Ponde DE, Blankemeyer E, Skovronsky D, Kilbourn MR, Kung HF. In vivo imaging of beta-cell mass in rats using 18F-FP-(+)-DTBZ: a potential PET ligand for studying diabetes mellitus. J Nucl Med. 2008 Jul;49(7):1171-6. doi: 10.2967/jnumed.108.051680. Epub 2008 Jun 13.
- Rickels MR, Naji A, Teff KL. Acute insulin responses to glucose and arginine as predictors of beta-cell secretory capacity in human islet transplantation. Transplantation. 2007 Nov 27;84(10):1357-60. doi: 10.1097/01.tp.0000287595.16442.a7.
- Souza F, Simpson N, Raffo A, Saxena C, Maffei A, Hardy M, Kilbourn M, Goland R, Leibel R, Mann JJ, Van Heertum R, Harris PE. Longitudinal noninvasive PET-based beta cell mass estimates in a spontaneous diabetes rat model. J Clin Invest. 2006 Jun;116(6):1506-13. doi: 10.1172/JCI27645. Epub 2006 May 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
August 12, 2009
First Submitted That Met QC Criteria
August 13, 2009
First Posted (Estimate)
August 14, 2009
Study Record Updates
Last Update Posted (Estimate)
July 23, 2012
Last Update Submitted That Met QC Criteria
July 20, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Y-003-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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