- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236754
Evaluation of 18F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass
Scan Re-Scan Pancreatic Beta Cell Imaging Using PET Imaging and 18F-FP-DTBZ
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Naomi Berrie Diabetes Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with type 1 diabetes may be enrolled if they meet all of the following criteria:
- Are males or females between 18 and 70 years of age, inclusive
- Have a diagnosis of type 1 diabetes mellitus as defined by the American Diabetes Association (ADA) criteria or by diagnosed as per their endocrinologist; duration >5 years; Insulin dose requirements <0.8 units/kg/day
- HbA1c level between 5% and 8.5%
- Have fasting C-Peptide < 0.1 ng/ml
- Have a body mass index (BMI) between 18 and 32 kg/m2
- Able to tolerate PET imaging
- In the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and Day 1 imaging procedures
- Give informed consent
Healthy volunteers may be enrolled if they meeting all of the following criteria:
- Are males or females between 18 and 70 years of age, inclusive
- Have no history of type 1 or type 2 diabetes in a first degree relative
- Fasting blood glucose less than 100 mg/dL
- HbA1c level less than 6%
- Normal Mixed Meal Tolerance test at screening visit
- BMI between 18 and 32 kg/m2
- Able to tolerate PET imaging
- In the judgment of the physician, are capable of fasting 4 to 6 hours prior to screening and Day 1 imaging procedures, and
- Give informed consent
Exclusion Criteria:
Potential participants must not have any of the following exclusion criteria:
- Clinically significant renal dysfunction
- Clinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (aspartate aminotransferase (AST), alanine aminotransferase (ALT), Total/Direct Bilirubin, Alkaline Phosphatase)
- Coagulopathy
- Use medications known to affect dopaminergic function, including monoamine oxidase (MAO) inhibitors, tetrabenazine, or levodopa
- Recent (within 3 months) or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. glucocorticoids, reserpine) medications known to affect dopaminergic function, including MAO inhibitors, tetrabenazine, or levodopa
- Have polycystic ovarian syndrome
- History of movement disorder such as Parkinson's Disease, Huntington's Disease
- Clinically significant psychiatric disease or history of psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia
- Current use (within past year) of cocaine, methamphetamine, and/or ecstasy (3,4methylenedioxymethamphetamine (MDMA))
- Have a recent history of alcohol or substance abuse or dependence
- Clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (ECG) (including but not limited to QTc > 450 msec)
- Clinically significant pulmonary, renal or hepatic impairment, or cancer
- Have clinically significant infectious disease, including acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection or previous positive test for hepatitis B, hepatitis C, HIV1, or HIV2
Are women of childbearing potential not refraining from sexual activity or not using adequate contraception.
Women must not be pregnant (negative serum human chorionic gonadotropin (hCG) at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant during for 30 days following the clinical trial
- Require medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
- Weigh more than the manufacturer recommended limit for the PET/computed tomography (CT) camera being used
- Any prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); And
- Have received a diagnostic or therapeutic radiopharmaceutical within the past week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Healthy Controls
Pancreatic 18F-FP-DTBZ uptake will be measured with PET scanning in healthy controls: subjects with predicted normal BCM (healthy, normal weight, non-diabetic individuals who have stimulated insulin and c-peptide levels within the normal range).
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The drug, no carrier added [18F]-FP-DTBZ, is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce [18F]-FP-DTBZ for injection.
Subjects will receive a single i.v.
administration of no more than 7.6 mCi of [18F]-FP-DTBZ for injection immediately prior to imaging.
The specific activity at time of injection will less than 1.0 mCi/microgram and thus for a 7.6 mCi dose the maximal mass dose will be less than 10 microgram.
Individuals will be imaged continuously (i.e.
dynamically) for 2 hours.
Other Names:
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OTHER: Patients with T1D
Pancreatic 18F-FP-DTBZ uptake will be measured with PET scanning in patients with longstanding T1D: subjects with predicted reduced beta cell mass (subjects with established T1DM who have low or no measurable stimulated insulin and c-peptide levels).
|
The drug, no carrier added [18F]-FP-DTBZ, is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce [18F]-FP-DTBZ for injection.
Subjects will receive a single i.v.
administration of no more than 7.6 mCi of [18F]-FP-DTBZ for injection immediately prior to imaging.
The specific activity at time of injection will less than 1.0 mCi/microgram and thus for a 7.6 mCi dose the maximal mass dose will be less than 10 microgram.
Individuals will be imaged continuously (i.e.
dynamically) for 2 hours.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean BPND (non-displaceable binding potential)
Time Frame: Up to 2 months from enrollment
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We will be evaluating pancreatic uptake of the radiotracer 18F-FP-DTBZ in subjects with and without long-standing type 1 diabetes mellitus.
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Up to 2 months from enrollment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chaitanya Divgi, MD, Columbia University
Publications and helpful links
General Publications
- Goland R, Freeby M, Parsey R, Saisho Y, Kumar D, Simpson N, Hirsch J, Prince M, Maffei A, Mann JJ, Butler PC, Van Heertum R, Leibel RL, Ichise M, Harris PE. 11C-dihydrotetrabenazine PET of the pancreas in subjects with long-standing type 1 diabetes and in healthy controls. J Nucl Med. 2009 Mar;50(3):382-9. doi: 10.2967/jnumed.108.054866. Epub 2009 Feb 17. Erratum In: J Nucl Med. 2009 Oct;50(10):1578.
- Freeby MJ, Kringas P, Goland RS, Leibel RL, Maffei A, Divgi C, Ichise M, Harris PE. Cross-sectional and Test-Retest Characterization of PET with [(18)F]FP-(+)-DTBZ for beta Cell Mass Estimates in Diabetes. Mol Imaging Biol. 2016 Apr;18(2):292-301. doi: 10.1007/s11307-015-0888-7. Epub 2015 Sep 14.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAJ5709
- R01DK077493-03 (NIH)
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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