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Dual-Tracer Theranostic PET

Primary Purpose

Neuroendocrine Tumors, Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-Tracer FDG PET/CT Exam
Single-Tracer Cu64-DOTATATE PET/CT Exam
Single-Tracer Ga68-DOTATATE PET/CT Exam
Single-Tracer PSMA PET/CT Exam
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring somatostatin receptor-positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Huntsman Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 22, 2022
Last Updated
July 11, 2023
Sponsor
University of Utah
Collaborators
MultiFunctional Imaging LLC, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05680675
Brief Title
Dual-Tracer Theranostic PET
Official Title
Dual-Tracer Theranostic PET
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
December 13, 2025 (Anticipated)
Study Completion Date
December 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
MultiFunctional Imaging LLC, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors, Prostate Cancer
Keywords
somatostatin receptor-positive

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT exam + Single-Tracer Cu64-DOTATATE PET/CT
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Single-Tracer FDG PET/CT exam + Single-Tracer Ga68-DOTATATE PET/CT exam
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Single-Tracer FDG PET/CT exam + Single-Tracer PSMA (prostate-specific membrane antigen) PET/CT exam
Intervention Type
Diagnostic Test
Intervention Name(s)
Single-Tracer FDG PET/CT Exam
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Single-Tracer Cu64-DOTATATE PET/CT Exam
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Single-Tracer Ga68-DOTATATE PET/CT Exam
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Single-Tracer PSMA PET/CT Exam
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of two PET/CT scans per patient as dictated by assigned arm
Description
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
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regan Butterfield
Phone
801-646-4193
Email
Regan.Butterfield@hci.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Yap, PhD
Organizational Affiliation
Huntsman Cancer Institute/ University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regan Butterfield
Phone
801-646-4193
Email
Regan.Butterfield@hci.utah.edu

12. IPD Sharing Statement

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Dual-Tracer Theranostic PET

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