Dual-Tracer Theranostic PET

Prostate Cancer Clinical Trial

Official title:

Dual-Tracer Theranostic PET

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05680675
• Other study ID #: HCI158172
• Secondary ID: 2R44CA257522
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: December 13, 2025

Study information

• Verified date: July 2023
• Source: University of Utah
• Contact: Regan Butterfield
• Phone: 801-646-4193
• Email: Regan.Butterfield[@]hci.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 13, 2025
• Est. primary completion date: December 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Prostate Cancer

Intervention

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.
• 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 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 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.

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	MultiFunctional Imaging LLC, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 FDG + Cu64-DOTATATE, FDG + Ga68-DOTATATE, and FDG + Ga68-PSMA-11 PET/CT	2 days