Trial Outcomes & Findings for Evaluation of 18 F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass (NCT NCT02236754)
NCT ID: NCT02236754
Last Updated: 2024-07-23
Results Overview
The VMAT2 functional binding capacity in the body and tail of the pancreas is calculated as BPND (VMAT2 binding potential) × PET ROI (region-of-interest) Volume. BPND is unitless, and ROI unit is mL. Higher values of the VMAT functional binding capacity indicates greater β cell mass.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Up to 2 months from enrollment
Results posted on
2024-07-23
Participant Flow
Potential subjects with diabetes were recruited at the Naomi Berri Diabetes Center. The physician ascertained from the patient that he/she is willing to discuss the study with the research team before the investigators approach the patient. Non-diabetic subjects were either be referred by their physicians, by word of mouth, or by flyer.
Participant milestones
| Measure |
Healthy Controls
Pancreatic 18 F-FP-DTBZ uptake will be measured with positron emission tomography (PET) scanning in healthy controls: subjects with predicted normal beta cell mass (BCM) (healthy, normal weight, non-diabetic individuals who have stimulated insulin and c-peptide levels within the normal range).
18 F-FP-DTBZ: The drug, no carrier added \[18 F\]-Fluoropropyl (FP)- dihydrotetrabenazine (DTBZ), is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce \[18 F\]-FP-DTBZ for injection. Subjects will receive a single i.v. administration of no more than 7.6 millicurie (mCi) of \[18 F\]-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.
PET Scanning: Individuals will be imaged continuously (i.e. dynamically) for 2 hours.
|
Patients With T1D
Pancreatic 18 F-FP-DTBZ uptake will be measured with PET scanning in patients with longstanding Type 1 Diabetes Mellitus (T1DM): subjects with predicted reduced beta cell mass (subjects with established T1DM who have low or no measurable stimulated insulin and c-peptide levels).
18 F-FP-DTBZ: The drug, no carrier added \[18 F\]-FP-DTBZ, is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce \[18 F\]-FP-DTBZ for injection. Subjects will receive a single i.v. administration of no more than 7.6 mCi of \[18 F\]-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.
PET Scanning: Individuals will be imaged continuously (i.e. dynamically) for 2 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
8
|
|
Overall Study
COMPLETED
|
14
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Healthy Controls
Pancreatic 18 F-FP-DTBZ uptake will be measured with positron emission tomography (PET) scanning in healthy controls: subjects with predicted normal beta cell mass (BCM) (healthy, normal weight, non-diabetic individuals who have stimulated insulin and c-peptide levels within the normal range).
18 F-FP-DTBZ: The drug, no carrier added \[18 F\]-Fluoropropyl (FP)- dihydrotetrabenazine (DTBZ), is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce \[18 F\]-FP-DTBZ for injection. Subjects will receive a single i.v. administration of no more than 7.6 millicurie (mCi) of \[18 F\]-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.
PET Scanning: Individuals will be imaged continuously (i.e. dynamically) for 2 hours.
|
Patients With T1D
Pancreatic 18 F-FP-DTBZ uptake will be measured with PET scanning in patients with longstanding Type 1 Diabetes Mellitus (T1DM): subjects with predicted reduced beta cell mass (subjects with established T1DM who have low or no measurable stimulated insulin and c-peptide levels).
18 F-FP-DTBZ: The drug, no carrier added \[18 F\]-FP-DTBZ, is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce \[18 F\]-FP-DTBZ for injection. Subjects will receive a single i.v. administration of no more than 7.6 mCi of \[18 F\]-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.
PET Scanning: Individuals will be imaged continuously (i.e. dynamically) for 2 hours.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Evaluation of 18 F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=14 Participants
Pancreatic 18 F-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).
18 F-FP-DTBZ: The drug, no carrier added \[18 F\]-FP-DTBZ, is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce \[18 F\]-FP-DTBZ for injection. Subjects will receive a single i.v. administration of no more than 7.6 mCi of \[18 F\]-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.
PET Scanning: Individuals will be imaged continuously (i.e. dynamically) for 2 hours.
|
Patients With T1D
n=8 Participants
Pancreatic 18 F-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).
18 F-FP-DTBZ: The drug, no carrier added \[18 F\]-FP-DTBZ, is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce \[18 F\]-FP-DTBZ for injection. Subjects will receive a single i.v. administration of no more than 7.6 mCi of \[18 F\]-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.
PET Scanning: Individuals will be imaged continuously (i.e. dynamically) for 2 hours.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 months from enrollmentThe VMAT2 functional binding capacity in the body and tail of the pancreas is calculated as BPND (VMAT2 binding potential) × PET ROI (region-of-interest) Volume. BPND is unitless, and ROI unit is mL. Higher values of the VMAT functional binding capacity indicates greater β cell mass.
Outcome measures
| Measure |
Study Controls
n=14 Participants
Healthy individuals with no familial history of diabetes
|
Longstanding T1D
n=8 Participants
Patients with Type 1 diabetes of duration longer than 5 years
|
|---|---|---|
|
Mean VMAT2 Functional Binding Capacity in the β Cells to 18 F-FP-DTBZ
|
103 unitless
Standard Error 12
|
38 unitless
Standard Error 5
|
Adverse Events
Study Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Longstanding T1D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place