Study on Using [18F]FTT PET Scans to Measure PARP Levels in Patients with Metastatic Breast Cancer

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT06502691

Provider View

This clinical trial is exploring how well a special PET scan using [18F]FTT can detect cancer in patients with metastatic breast cancer who are receiving standard treatments, including PARP inhibitors and possibly immune checkpoint inhibitors.

Patient Parameters

Program Overview

This study is testing a new imaging method using a PET scan with a tracer called [18F]FTT to see if it can better detect cancer in patients with breast cancer that has spread to other parts of the body. The tracer binds to a protein called PARP1, which is involved in cancer cell repair. By using this PET scan, doctors hope to see how well the cancer responds to treatments like PARP inhibitors, which block the repair process and may help kill cancer cells. Some patients may also receive immune checkpoint inhibitors, which help the immune system attack cancer cells. The goal is to improve the detection of cancer cells in patients undergoing these treatments.

Description

In this study, patients are divided into two groups:

  • Group 1: Patients will receive an injection of [18F]FTT and have a PET scan about an hour later. This will happen on the first day they start their standard treatment with PARP inhibitors, with or without immune checkpoint inhibitors. They will have another PET scan at 12 weeks. After 1-7 days, they will have a standard PET/CT scan and follow-up scans at 12 weeks and 6 months. Some patients may also have a tissue biopsy during the study.

  • Group 2: Patients will receive an injection of [18F]FTT and have a PET scan about an hour later on the first day of their standard treatment. After 1-7 days, they will have a standard PET/CT scan and follow-up scans at 12 weeks and 6 months. Some patients may also have a tissue biopsy during the study.

After the initial [18F]FTT PET scan, patients will be monitored for up to 6 months or until their disease progresses.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed invasive breast cancer that has spread to other parts of the body.
  • Be eligible for treatment with PARP inhibitors, either alone or with immune checkpoint inhibitors, as decided by the doctor.
  • Have cancer that can be measured by scans.
  • Be 18 years or older.
  • Have a performance status score indicating they are able to carry out daily activities with some limitations.
  • Provide a previous tissue sample from a metastatic site, or be willing to have a biopsy if no sample is available.
  • Be willing to have a biopsy if a follow-up [18F]FTT PET scan is done at 12 weeks.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and before any follow-up [18F]FTT PET scan.
  • Agree to use effective birth control during the study.
  • Be willing to follow the study procedures and attend all visits.
  • Understand and agree to sign a consent form before starting the study.

Exclusion Criteria

  • Have a history of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Be pregnant or breastfeeding.
  • Have an allergy to the PARP inhibitor used in the study.
  • Have uncontrolled health issues such as infections, heart problems, or mental health conditions that would interfere with the study.
  • Be unable to swallow pills or have digestive issues that affect medication absorption.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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