Actively Recruiting
[18F]FTT Positron Emission Tomography (PET) in Patients With Metastatic Breast Cancer
Led by University of Washington · Updated on 2026-05-19
22
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
B
Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well fluorine F 18 fluorthanatrace ([18F]FTT) positron emission tomography (PET) works in imaging patients with metastatic breast cancer who are receiving standard treatments using PARP inhibitors, with or without immune checkpoint inhibitors (ICI). This study focuses on detecting how tumors respond clinically to these treatments by targeting and visualizing PARP1 expression in tumor cells using the [18F]FTT tracer during PET scans. PARP inhibitors block an enzyme involved in repairing cell damage, potentially causing tumor cells to die, while ICIs may assist the immune system in attacking cancer and slowing tumor growth. Participants are assigned to one of two groups. In Arm I, patients receive [18F]FTT intravenously and undergo PET scans 60-75 minutes later on the first day of starting PARP inhibitor treatment with or without ICI, and again at 12 weeks. Following this, they have standard FDG PET/CT scans and follow-ups at 12 weeks and 6 months, with optional tissue biopsies during screening and follow-up. In Arm II, patients receive [18F]FTT and PET scans similarly on day 1 but only have follow-up FDG PET/CT scans and may have biopsies during screening. After initial imaging, patients are monitored for up to 6 months or until disease progression. During the study, participants undergo several assessments including [18F]FTT PET scans, FDG PET/CT scans, tissue biopsies, and health record reviews. Researchers measure the overall response rate up to 6 months to evaluate tumor response to treatment. Safety and progression are monitored throughout, with multiple imaging and biopsy timepoints to track changes. Participation involves scheduled visits for imaging and scans, with treatment and evaluations following standard care protocols.
CONDITIONS
Brief Title
[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically confirmed invasive breast cancer with metastatic disease
- Patients must be candidates for treatment with PARP inhibitor as a single agent or in combination with an immune checkpoint inhibitor
- Patients must have evaluable disease or at least one measurable lesion assessable by CT or MRI per RECIST 1.1
- Age 18 years or older
- Karnofsky performance status (KPS) 50% or higher or ECOG performance status 0 to 2
- Archival tissue from at least one metastatic site biopsy available before enrollment or biopsy during screening
- Willingness to undergo on-treatment biopsy if on-treatment [18F]FTT PET is performed
- For women of childbearing potential, negative pregnancy test within 7 days prior to [18F]FTT PET imaging on day 1 and before 12-week imaging if applicable
- Men and women of reproductive potential must agree to use two effective forms of contraception during the study
- Ability and willingness to comply with study procedures and sign informed consent
You will not qualify if you...
- History of myelodysplastic syndrome or acute myeloid leukemia related to PARP inhibitor therapy
- Pregnant or breastfeeding women
- Known hypersensitivity to PARP inhibitor products
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
- Inability to swallow oral medication or gastrointestinal disorders interfering with PARP inhibitor absorption
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits including possible tissue biopsy
Duration - 1 week
Participants receive an intravenous injection of [18F]FTT and undergo a PET scan 60-75 minutes later on day 1 of starting standard of care PARP inhibitor with or without immune checkpoint inhibitor therapy. At least 1 to 7 days later, participants undergo a standard of care FDG PET/CT scan.
2 visits (in-person) within 1 week
Duration - Up to 6 months
Participants are followed with repeat [18F]FTT PET scans at 12 weeks (Arm I only) and FDG PET/CT scans at 12 weeks and 6 months. Some participants may undergo follow-up tissue biopsies. Participants are monitored for up to 6 months or until disease progression.
3 to 4 visits (in-person) over 6 months
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
J
Jennifer Specht, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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