Dual-Tracer Theranostic PET | NCT05680675

NCT05680675

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2R44CA257522	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
MultiFunctional Imaging LLC	UNKNOWN
National Cancer Institute (NCI)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT exam + Single-Tracer Cu64-DOTATATE PET/CT	Diagnostic Test: Single-Tracer FDG PET/CT Exam Diagnostic Test: Single-Tracer Cu64-DOTATATE PET/CT Exam
Arm 2	Experimental	Single-Tracer FDG PET/CT exam + Single-Tracer Ga68-DOTATATE PET/CT exam	Diagnostic Test: Single-Tracer FDG PET/CT Exam Diagnostic Test: Single-Tracer Ga68-DOTATATE PET/CT Exam
Arm 3	Experimental	Single-Tracer FDG PET/CT exam + Single-Tracer PSMA (prostate-specific membrane antigen) PET/CT exam	Diagnostic Test: Single-Tracer FDG PET/CT Exam Diagnostic Test: Single-Tracer PSMA PET/CT Exam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single-Tracer FDG PET/CT Exam	Diagnostic Test	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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 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.

Name	Affiliation	Role
Jeffrey A Yap, PhD	Huntsman Cancer Institute/ University of Utah	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Huntsman Cancer Institute		Salt Lake City	Utah	84112	United States

Arm/Group Information

ID	Title	Description
FG000	Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams	Single-Tracer FDG PET/CT Exam: 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. 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.
FG001	Single-Tracer FDG PET/CT + Single-Tracer Ga68-DOTATATE PET/CT Exams	Single-Tracer FDG PET/CT Exam: 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. 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.
FG002	Single-Tracer FDG PET/CT + Single-Tracer PSMA (Prostate-specific Membrane Antigen) PET/CT Exams	Single-Tracer FDG PET/CT Exam: 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. 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams	Single-Tracer FDG PET/CT Exam: 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. 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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 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

All participants enrolled on trial completed two different PET/CT scans within a two week span.

Posted

Count of Units

PET/CT scans

PET/CT exams were obtained on two separate days within a two week span.

PET/CT scans

ID	Title	Description
OG000	Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams	Single-Tracer FDG PET/CT Exam: 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. 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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Single-Tracer FDG (F18 Fluorodeoxyglucose) PET/CT + Single-Tracer Cu64-DOTATATE PET/CT Exams	Single-Tracer FDG PET/CT Exam: 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. 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 17, 2023	Jan 14, 2025	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Oct 10, 2023	Aug 30, 2024	ICF_001.pdf

ID	Term
D018358	Neuroendocrine Tumors
D011471	Prostatic Neoplasms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms