RecruitingPhase 1Phase 2NCT06502691

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

[18F]FTT Positron Emission Tomography (PET) in Patients With Metastatic Breast Cancer


Sponsor

University of Washington

Enrollment

22 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specialized PET scan imaging agent called [18F]FTT to measure levels of a protein called PARP in metastatic breast cancer tumors. PARP is targeted by a class of drugs called PARP inhibitors, and this scan could help predict which patients will respond to those drugs. **You may be eligible if...** - You have confirmed invasive metastatic breast cancer - Your doctor is considering treating you with a PARP inhibitor (either alone or with an immunotherapy drug) - You have measurable disease on standard CT or MRI scans - You are 18 or older with reasonable functional status - Tumor tissue from a biopsy site is available (or you are willing to have a biopsy) - You are willing to use contraception and undergo a follow-up biopsy if required **You may NOT be eligible if...** - You have a history of myelodysplastic syndrome or acute myeloid leukemia - You are pregnant or breastfeeding - You have a known allergy to the PARP inhibitor being used - You have uncontrolled illness including active infection, heart failure, or significant psychiatric illness - You cannot swallow pills or have severe gut absorption problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Receive of standard care

PROCEDUREBiopsy of Breast

Undergo breast biopsy

PROCEDUREComputed Tomography

Undergo FDG PET/CT

OTHERElectronic Health Record Review

Ancillary studies

OTHERFludeoxyglucose F-18

Given FDG

RADIATIONFluorine F 18 Fluorthanatrace

Given IV

DRUGImmune Checkpoint Inhibitor

Receive ICI treatment

DRUGPoly (ADP-Ribose) Polymerase Inhibitor

Receive PARP inhibitor treatment

PROCEDUREPositron Emission Tomography

Undergo \[18F\]FTT PET

PROCEDUREPositron Emission Tomography

Undergo FDG PET/CT


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT06502691


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