Neuroendocrine Tumors, Prostate Cancer
Conditions
Keywords
somatostatin receptor-positive
Brief summary
This study is designed to obtain positron emission tomography with x-ray computed tomography (PET/CT) imaging data with each tracer pair, providing the imaging data needed to develop new simultaneous dual-tracer imaging techniques and processing algorithms for these tracer pairs.
Interventions
DIAGNOSTIC_TESTSingle-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.
DIAGNOSTIC_TESTSingle-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.
DIAGNOSTIC_TESTSingle-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.
DIAGNOSTIC_TESTSingle-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.
Sponsors
MultiFunctional Imaging LLC
National Cancer Institute (NCI)
University of Utah
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults aged 18 years or greater. * willing and able to sign a written informed consent and HIPAA authorization in accordance with local and institutional guidelines. * presence of at least 1 measurable lesion ≥ 1 cm in size. * willing to have their clinical records reviewed for at least 24 months after enrollment. * willing to lie flat on their back in the PET/CT scanner for up to one hour to allow for the imaging data to be obtained. * willing to undergo two separate PET/CT exams on different days within 2 weeks of each other. * female participants who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans. The serum pregnancy test must be performed within 48 hours prior to research PET imaging. A negative test will be necessary for such patients to undergo research PET imaging. This only applies to Arms 1 and 2, since only males will be included in Arm 3 (only males can get prostate cancer). * Arms 1 and 2 only: known or suspected somatostatin receptor-positive neuroendocrine tumor (NET) who could be considered for clinical use of DOTATATE PET/CT imaging under the approved indications for use of this radiopharmaceutical according to published appropriate use criteria. These indications include initial staging after the histologic diagnosis of NET, evaluation of an unknown primary; evaluation of a mass suggestive of NET not amenable to endoscopic or percutaneous biopsy, staging of NET before planned surgery, monitoring of NET seen predominantly on somatostatin receptor (SSTR) PET, evaluation of patients with biochemical evidence and symptoms of a NET, evaluation of patients with biochemical evidence of a NET without evidence on conventional imaging or a prior histologic diagnosis, restaging at time of clinical or laboratory progression without progression on conventional imaging, and new indeterminate lesion on conventional imaging with unclear progression. * Arm 3 Only: known or suspected prostate cancer who could be considered for clinical use of PSMA PET/CT imaging under the approved indications for use of this radiopharmaceutical, including patients with suspected metastasis and patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Exclusion criteria
* received somatostatin receptor targeted therapy at any time prior to enrollment will be excluded from the study Arms involving DOTATATE (Arms 1-2). * known intolerance or hypersensitivity to any somatostatin analogs will be excluded from the study Arms involving DOTATATE (Arms 1-2). * participated in any therapeutic clinical study or received any investigational agent within the last 30 days. * known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals * require monitored anesthesia for PET/CT scanning. * too claustrophobic to undergo PET/CT scanning. * exceed the 450 lb. weight limit of the PET/CT scanner. * pregnant or currently breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm | PET/CT exams were obtained on two separate days 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| 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. | 20 |
| Total | 50 |
Baseline characteristics
| Characteristic | Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams | Total | Single-Tracer FDG PET/CT + Single-Tracer PSMA (Prostate-specific Membrane Antigen) PET/CT Exams | Single-Tracer FDG PET/CT + Single-Tracer Ga68-DOTATATE PET/CT Exams |
|---|---|---|---|---|
| Age, Continuous | 56.74 Years STANDARD_DEVIATION 19.74 | 60.84 Years STANDARD_DEVIATION 15.87 | 68.22 Years STANDARD_DEVIATION 11.74 | 54.25 Years STANDARD_DEVIATION 12.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 46 Participants | 17 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 44 Participants | 16 Participants | 13 Participants |
| Region of Enrollment United States | 15 Participants | 50 Participants | 20 Participants | 15 Participants |
| Sex: Female, Male Female | 12 Participants | 20 Participants | 0 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 30 Participants | 20 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 20 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 20 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 20 |
Outcome results
Primary
Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm
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
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams | Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm | 30 PET/CT scans |
| Single-Tracer FDG PET/CT + Single-Tracer Ga68-DOTATATE PET/CT Exams | Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm | 30 PET/CT scans |
| Single-Tracer FDG PET/CT + Single-Tracer PSMA (Prostate-specific Membrane Antigen) PET/CT Exams | Completion of Two PET/CT Scans Per Patient as Dictated by Assigned Arm | 40 PET/CT scans |