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Dual-Tracer Theranostic PET | Clinical Trials | Clareo Health

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Dual-Tracer Theranostic PET

NCT05680675•University of Utah

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

December 8, 2022

Primary Completion Date

June 4, 2024

Completion Date

June 4, 2024

Last Updated

February 6, 2025

Enrollment

ACTUAL participants

Conditions

Neuroendocrine TumorsProstate Cancer

Interventions

Single-Tracer FDG PET/CT Exam

DIAGNOSTIC_TEST

Single-Tracer Cu64-DOTATATE PET/CT Exam

DIAGNOSTIC_TEST

Single-Tracer Ga68-DOTATATE PET/CT Exam

DIAGNOSTIC_TEST

Single-Tracer PSMA PET/CT Exam

DIAGNOSTIC_TEST

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

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RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dual-Tracer Theranostic PET

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors