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A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG

Primary Purpose

Prostate Cancer, Breast Cancer, Neuroendocrine Tumors

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Total-body PET imaging

About this trial

This is an interventional basic science trial for Prostate Cancer

Eligibility Criteria

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

18F-PSMA (n=3)

Inclusion criteria:

Men >18 yo with suspected prostate cancer metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level
Prior imaging study (CT, and/or MRI and/or Bone scan and/or Fluciclovine scan) suspicious for metastatic disease, obtained not earlier than 4 months from the research scan date.
68Ga DOTATATE (n=3)

Inclusion Criteria:

Persons > 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs)
Prior DOTATATE PET/CT scan suspicious for tumor obtained not earlier than 4 months from the research scan date.

Exclusion Criteria:

Recent administration of long-acting somatostatin analogs
18F-FES (n=3):
Persons > 18 yo with recurrent or metastatic breast cancer
Prior imaging study (CT, and/or US, and/or MRI, and/or bone scan and/or FDG PET/CT) suspicious for tumor, obtained not earlier than 4 months from the research scan date.
Biopsy proven ER-positive breast cancer (any location) in the past 6 months

Exclusion Criteria:

• History of ER modulators and ER down-regulators such as tamoxifen and fulvestrant in the past 8 and 28 weeks, respectively

Exclusion Criteria for all participants:

Adults unable to consent
Pregnant/lactating persons
Prisoners
Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner
Uncontrolled claustrophobia
Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety

Sites / Locations

UC Davis EXPLORER Molecular Imaging Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Total-body PET scan

Arm Description

All participants will receive a dynamic PET scan for up to 90 minutes. This will be followed by two 30 minutes static PET scans at 3 hours +/-20 minutes and 6 hours +/-20 minutes post injection. Subjects injected with 18F-PSMA or 18F-FES will receive a 40 minute scan at 9 hours +/-20 minutes post injection.

Outcomes

Primary Outcome Measures

measure radiotracer avidity

measure radiotracer avidity, i.e. standardized uptake value measurements (SUV max and mean) of tumor and normal tissue as a function of time with 18F-PSMA, 18F-FES, 68Ga DOTATATE in a total-body PET scanner among men with suspected prostate cancer metastasis, patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors, and patients with recurrent or metastatic breast cancer.

Secondary Outcome Measures

Full Information

NCT ID

NCT05160480

First Posted

December 2, 2021

Last Updated

September 7, 2023

Sponsor

University of California, Davis

Collaborators

Lantheus Medical Imaging

1. Study Identification

Unique Protocol Identification Number

NCT05160480

Brief Title

A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG

Official Title

A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

Collaborators

Lantheus Medical Imaging

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this research study is to test new ways to improve the usefulness of the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER) by collecting data from PET scans using one of three different imaging agents: 18F-PSMA; 18F-FES; or, 68Ga DOTATATE. These imaging agents are approved by the FDA to be used for patients diagnosed with prostate cancer (18F-PSMA), neuroendocrine tumor (68Ga DOTATATE), or breast cancer (18F-FES).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Breast Cancer, Neuroendocrine Tumors

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Total-body PET scan

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Total-body PET imaging

Intervention Description

Total-body PET imaging at different timepoints

Primary Outcome Measure Information:

Title

measure radiotracer avidity

Description

Time Frame

One study imaging visit lasting up to 10 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

18F-PSMA (n=3) Inclusion criteria: Men >18 yo with suspected prostate cancer metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level Prior imaging study (CT, and/or MRI and/or Bone scan and/or Fluciclovine scan) suspicious for metastatic disease, obtained not earlier than 4 months from the research scan date. 68Ga DOTATATE (n=3) Inclusion Criteria: Persons > 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs) Prior DOTATATE PET/CT scan suspicious for tumor obtained not earlier than 4 months from the research scan date. Exclusion Criteria: Recent administration of long-acting somatostatin analogs 18F-FES (n=3): Persons > 18 yo with recurrent or metastatic breast cancer Prior imaging study (CT, and/or US, and/or MRI, and/or bone scan and/or FDG PET/CT) suspicious for tumor, obtained not earlier than 4 months from the research scan date. Biopsy proven ER-positive breast cancer (any location) in the past 6 months Exclusion Criteria: • History of ER modulators and ER down-regulators such as tamoxifen and fulvestrant in the past 8 and 28 weeks, respectively Exclusion Criteria for all participants: Adults unable to consent Pregnant/lactating persons Prisoners Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner Uncontrolled claustrophobia Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lynda Painting

Phone

916-731-9004

lpainting@ucdavis.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Dana Little, MS

Phone

916-734-7749

dlittle@ucdavis.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorenzo Nardo, MD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis EXPLORER Molecular Imaging Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG

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