Dual-Tracer Theranostic PET

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 SSTR (somatostatin receptor) 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05680675
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Utah
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jeffrey A Yap, PhD
Principal Investigator Affiliation Huntsman Cancer Institute/ University of Utah
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors, Prostate Cancer
Arms & Interventions

Arms

Experimental: Arm 1

Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT exam + Single-Tracer Cu64-DOTATATE PET/CT

Experimental: Arm 2

Single-Tracer FDG PET/CT exam + Single-Tracer Ga68-DOTATATE PET/CT exam

Experimental: Arm 3

Single-Tracer FDG PET/CT exam + Single-Tracer PSMA (prostate-specific membrane antigen) PET/CT exam

Interventions

Diagnostic Test: - Single-Tracer FDG PET/CT Exam

The PET technologist will administer approximately 15 mCi (millicuries) 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 Test: - 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.

Diagnostic Test: - 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.

Diagnostic Test: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Site Contact

Regan Butterfield

[email protected]

801-646-4193

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