[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer
NCT ID: NCT06502691
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2025-11-22
2030-12-31
Brief Summary
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Detailed Description
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Arm I: Patients receive \[18F\]FTT intravenously (IV) and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/computed tomography (CT) and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
Arm II: Patients receive \[18F\]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
After initial \[18F\]FTT PET imaging, patients are followed-up to 6 months or until disease progression.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm I ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive \[18F\]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy and again at 12 weeks. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening and during follow up.
Best Practice
Receive of standard care
Biopsy of Breast
Undergo breast biopsy
Computed Tomography
Undergo FDG PET/CT
Electronic Health Record Review
Ancillary studies
Fludeoxyglucose F-18
Given FDG
Fluorine F 18 Fluorthanatrace
Given IV
Immune Checkpoint Inhibitor
Receive ICI treatment
Poly (ADP-Ribose) Polymerase Inhibitor
Receive PARP inhibitor treatment
Positron Emission Tomography
Undergo \[18F\]FTT PET
Positron Emission Tomography
Undergo FDG PET/CT
Arm II ([18F]FTT PET, FDG PET/CT, PARP inhibitor, ICI)
Patients receive \[18F\]FTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ± ICI therapy. At least 1-7 days later, patients undergo SOC FDG PET/CT and follow up scans at 12 weeks and 6 months. Patients may also undergo tissue biopsy during screening.
Best Practice
Receive of standard care
Biopsy of Breast
Undergo breast biopsy
Computed Tomography
Undergo FDG PET/CT
Electronic Health Record Review
Ancillary studies
Fludeoxyglucose F-18
Given FDG
Fluorine F 18 Fluorthanatrace
Given IV
Immune Checkpoint Inhibitor
Receive ICI treatment
Poly (ADP-Ribose) Polymerase Inhibitor
Receive PARP inhibitor treatment
Positron Emission Tomography
Undergo \[18F\]FTT PET
Positron Emission Tomography
Undergo FDG PET/CT
Interventions
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Best Practice
Receive of standard care
Biopsy of Breast
Undergo breast biopsy
Computed Tomography
Undergo FDG PET/CT
Electronic Health Record Review
Ancillary studies
Fludeoxyglucose F-18
Given FDG
Fluorine F 18 Fluorthanatrace
Given IV
Immune Checkpoint Inhibitor
Receive ICI treatment
Poly (ADP-Ribose) Polymerase Inhibitor
Receive PARP inhibitor treatment
Positron Emission Tomography
Undergo \[18F\]FTT PET
Positron Emission Tomography
Undergo FDG PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be candidates for treatment with PARP inhibitor as a single agent or for PARP inhibitor in combination with an ICI per treating physician discretion
* Patients must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or magnetic resonance imaging \[MRI\]) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Age \>= 18 years
* Karnofsky performance status (KPS) \>= 50% or Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Archival tissue (formalin-fixed paraffin-embedded \[FFPE\]) from at least one metastatic site biopsy should be available prior to study enrollment; if archival tissue is not available, then a metastatic site biopsy will be required during the study screening period
* Patient must be willing to proceed with an on-treatment biopsy of metastatic site if an on-treatment \[18F\]FTT PET will be performed (at 12 ± 4 weeks after starting PARP inhibitor ± ICI treatment)
* For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to \[18F\]FTT PET imaging on day 1. For women who obtain on-treatment (12-week) \[18F\]FTT imaging, a negative serum pregnancy test will be required within 7 days prior to \[18F\]FTT PET imaging
* Men and women of reproductive potential need to agree to employ two highly effective and acceptable forms of contraception throughout their participation in the study
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
* Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures
Exclusion Criteria
* Pregnant or breastfeeding women
* Patient with a known hypersensitivity to the proposed PARP inhibitor product
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of PARP inhibitor therapy (per investigator's discretion)
18 Years
ALL
No
Sponsors
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Breast Cancer Research Foundation
OTHER
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Jennifer Specht, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Jennifer Specht, MD
Role: primary
Other Identifiers
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NCI-2024-04929
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHIRB0020495
Identifier Type: OTHER
Identifier Source: secondary_id
RG1124440
Identifier Type: -
Identifier Source: org_study_id