Trial Outcomes & Findings for Dual-Tracer Theranostic PET (NCT NCT05680675)
NCT ID: NCT05680675
Last Updated: 2025-02-06
Results Overview
To obtain PET/CT imaging data suitable for developing new simultaneous dual-tracer PET techniques and processing algorithms for dual-tracer imaging of Fluorine-18 fluorodeoxyglucose (FDG) + Cu64-dodecane tetraacetic acid (DOTA) tyrosine-3-octreotate (TATE) (DOTATATE), FDG + Ga68-DOTATATE, and FDG + Ga68-prostate-specific membrane antigen (PSMA)-11 PET/CT
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
PET/CT exams were obtained on two separate days within a two week span.
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer Cu64-DOTATATE PET/CT Exam: The PET technologist will administer with approximately 4 mCi Cu64-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
Single-Tracer FDG PET/CT + Single-Tracer Ga68-DOTATATE PET/CT Exams
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer Ga68-DOTATATE PET/CT Exam: The PET technologist will administer with with approximately 5 mCi Ga68-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
Single-Tracer FDG PET/CT + Single-Tracer PSMA (Prostate-specific Membrane Antigen) PET/CT Exams
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer PSMA PET/CT Exam: The PET technologist will administer with with approximately 7 mCi Ga68-PSMA-11 intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
20
|
|
Overall Study
COMPLETED
|
15
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dual-Tracer Theranostic PET
Baseline characteristics by cohort
| Measure |
Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams
n=15 Participants
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer Cu64-DOTATATE PET/CT Exam: The PET technologist will administer with approximately 4 mCi Cu64-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
Single-Tracer FDG PET/CT + Single-Tracer Ga68-DOTATATE PET/CT Exams
n=15 Participants
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer Ga68-DOTATATE PET/CT Exam: The PET technologist will administer with with approximately 5 mCi Ga68-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
Single-Tracer FDG PET/CT + Single-Tracer PSMA (Prostate-specific Membrane Antigen) PET/CT Exams
n=20 Participants
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer PSMA PET/CT Exam: The PET technologist will administer with with approximately 7 mCi Ga68-PSMA-11 intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.74 Years
STANDARD_DEVIATION 19.74 • n=5 Participants
|
54.25 Years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
68.22 Years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
60.84 Years
STANDARD_DEVIATION 15.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: PET/CT exams were obtained on two separate days within a two week span.Population: All participants enrolled on trial completed two different PET/CT scans within a two week span.
To obtain PET/CT imaging data suitable for developing new simultaneous dual-tracer PET techniques and processing algorithms for dual-tracer imaging of Fluorine-18 fluorodeoxyglucose (FDG) + Cu64-dodecane tetraacetic acid (DOTA) tyrosine-3-octreotate (TATE) (DOTATATE), FDG + Ga68-DOTATATE, and FDG + Ga68-prostate-specific membrane antigen (PSMA)-11 PET/CT
Outcome measures
| Measure |
Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams
n=30 PET/CT scans
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer Cu64-DOTATATE PET/CT Exam: The PET technologist will administer with approximately 4 mCi Cu64-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
Single-Tracer FDG PET/CT + Single-Tracer Ga68-DOTATATE PET/CT Exams
n=30 PET/CT scans
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer Ga68-DOTATATE PET/CT Exam: The PET technologist will administer with with approximately 5 mCi Ga68-DOTATATE intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
Single-Tracer FDG PET/CT + Single-Tracer PSMA (Prostate-specific Membrane Antigen) PET/CT Exams
n=40 PET/CT scans
Single-Tracer FDG PET/CT Exam: The PET technologist will administer approximately 15 millicuries (mCi) of FDG intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
Single-Tracer PSMA PET/CT Exam: The PET technologist will administer with with approximately 7 mCi Ga68-PSMA-11 intravenously, and the participant will remain resting during the tracer uptake period. A CT topogram will be obtained, and the PET imaging field-of-view (FOV) selected. The PET scan will then be acquired, acquiring 5 back-to-back "whole-body" (eyes-to-thighs, or similar) scans, providing 5 sequential PET images.
|
|---|---|---|---|
|
Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm
|
30 PET/CT scans
|
30 PET/CT scans
|
40 PET/CT scans
|
Adverse Events
Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-Tracer FDG PET/CT + Single-Tracer Ga68-DOTATATE PET/CT Exams
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-Tracer FDG PET/CT + Single-Tracer PSMA (Prostate-specific Membrane Antigen) PET/CT Exams
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
Sam Mitchell
Huntsman Cancer Institute, Center for Quantitative Cancer Imaging
Phone: 801-213-6110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place