Dual-Tracer Theranostic PET
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2022
CompletedFirst Submitted
Initial submission to the registry
December 22, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2024
CompletedResults Posted
Study results publicly available
February 6, 2025
CompletedFebruary 6, 2025
January 1, 2025
1.5 years
December 22, 2022
December 13, 2024
January 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
PET/CT exams were obtained on two separate days within a two week span.
Study Arms (3)
Arm 1
EXPERIMENTALSingle-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT exam + Single-Tracer Cu64-DOTATATE PET/CT
Arm 2
EXPERIMENTALSingle-Tracer FDG PET/CT exam + Single-Tracer Ga68-DOTATATE PET/CT exam
Arm 3
EXPERIMENTALSingle-Tracer FDG PET/CT exam + Single-Tracer PSMA (prostate-specific membrane antigen) PET/CT exam
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- MultiFunctional Imaging LLCcollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sam Mitchell
- Organization
- Huntsman Cancer Institute, Center for Quantitative Cancer Imaging
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey A Yap, PhD
Huntsman Cancer Institute/ University of Utah
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2022
First Posted
January 11, 2023
Study Start
December 8, 2022
Primary Completion
June 4, 2024
Study Completion
June 4, 2024
Last Updated
February 6, 2025
Results First Posted
February 6, 2025
Record last verified: 2025-01