Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06502691

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

Led by University of Washington · Updated on 2026-03-02

22

Participants Needed

1

Research Sites

252 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have confirmed invasive breast cancer with metastatic disease
  • Patients must be candidates for PARP inhibitor treatment alone or combined with immune checkpoint inhibitor
  • Patients must have measurable disease or at least one lesion assessable by CT or MRI at baseline
  • Age 18 years or older
  • Karnofsky performance status (KPS) of 50% or higher or ECOG performance status of 0 to 2
  • Archival tissue from at least one metastatic biopsy available or willing to undergo biopsy during screening
  • Willing to have on-treatment biopsy if undergoing 12-week [18F]FTT PET scan
  • Women of childbearing potential must have a negative pregnancy test within 7 days before [18F]FTT PET imaging
  • Men and women of reproductive potential must agree to use two effective contraceptive methods during the study
  • Willing and able to comply with study procedures and visits
  • Able to understand and sign informed consent prior to study procedures
Not Eligible

You will not qualify if you...

  • History of myelodysplastic syndrome or acute myeloid leukemia related to PARP inhibitor therapy
  • Pregnant or breastfeeding women
  • Known allergy to the PARP inhibitor used in the study
  • Uncontrolled illnesses such as active infection, severe heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance
  • Unable to swallow oral medications or having gastrointestinal disorders interfering with PARP inhibitor absorption as judged by investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

J

Jennifer Specht, MD

CONTACT

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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