[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06502691
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Receive of standard care
  • Biopsy of Breast — PROCEDURE
    Undergo breast biopsy
  • Computed Tomography — PROCEDURE
    Undergo FDG PET/CT
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Fludeoxyglucose F-18 — OTHER
    Given FDG
  • Fluorine F 18 Fluorthanatrace — RADIATION
    Given IV
  • Immune Checkpoint Inhibitor — DRUG
    Receive ICI treatment
  • Poly (ADP-Ribose) Polymerase Inhibitor — DRUG
    Receive PARP inhibitor treatment
  • Positron Emission Tomography — PROCEDURE
    Undergo \[18F\]FTT PET
  • Positron Emission Tomography — PROCEDURE
    Undergo FDG PET/CT

Study Details

This clinical trial studies how well fluorine F 18 fluorthanatrace (\[18F\]FTT) positron emission tomography (PET) works in imaging patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving standard of care (SOC) poly (ADP-ribose) polymerase (PARP) inhibitors with or without immune checkpoint inhibitors (ICI) to be able to detect clinical response to PARP inhibitor ± ICI treatment. \[18F\]FTT is a radiotracer that targets and binds to PARP1 which can potentially be used for the imaging of PARP1 expression using PET. Once administered, \[18F\]FTT targets and binds to PARP1. Upon PET, PARP1-expressing tumor cells can be visualized. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case, \[18F\]FTT. Because some cancers take up \[18F\]FTT it can be seen with PET. PARP inhibitors work as a targeted therapy by blocking an enzyme involved in repairing cell damage. It may cause tumor cells to die. ICI may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Combining \[18F\]FTT with a PET scan may help detect tumor cells better in patients with metastatic breast cancer who are receiving standard of care PARP inhibitors with our without ICI treatment.

Key Dates

Start date
Feb 26, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Baseline up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Jennifer Specht, MD
[email protected]
206-606-6889
Jennifer Specht, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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