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

{ "\[18F\]FTT PET Imaging for Metastatic Breast Cancer", "This study is looking at how well a special imaging scan, called fluorine F 18 fluorthanatrace (\[18F\]FTT) PET, can detect a protein called PARP1 in metastatic breast cancer. This scan helps doctors see if PARP1-targeting treatments, like PARP inhibitors (drugs that block PARP activity) with or without immune checkpoint inhibitors (drugs that help your immune system fight cancer), are working. You might be able to join if you have breast cancer that has spread (metastatic breast cancer) and your doctor thinks you could benefit from a PARP inhibitor. The main goal is to see how many patients respond to treatment, measured over six months. The study is currently unclear on its recruitment status and plans to enroll 22 people.", "design": "This interventional study is not assigned a phase and plans to enroll 22 participants. It has two arms, where participants receive different schedules of imaging and biopsies.", "commitments": "You would receive \[18F\]FTT intravenously and undergo PET scans. You would also have standard of care FDG PET/CT scans and may undergo tissue biopsies during screening and follow-up. This would occur over a period of up to 6 months.", "compensation": "Not stated in the trial record.", "follow_up": "You will be followed up to 6 months or until your disease progresses." }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE1Ages 18+InterventionalDiagnostic

University of Washington

~22 participants

Updated 2026-05-19 on ClinicalTrials.gov

What's tested:Best PracticeBiopsy of BreastComputed TomographyElectronic Health Record ReviewFludeoxyglucose F-18Fluorine F 18 Fluorthanatrace

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Overall response rate (ORR)

Measured over Baseline up to 6 months

Conditions

Anatomic Stage IV Breast Cancer AJCC v8

Metastatic Breast Carcinoma

Where it's being run

1 sites across 1 states

Washington1

Study leadership

Jennifer Specht, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Jennifer Specht, MD

[email protected]

206-606-6889

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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 for PARP inhibitor in combination with an ICI per treating physician discretion

Patients must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or magnetic resonance imaging \[MRI\]) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Age \>= 18 years

Karnofsky performance status (KPS) \>= 50% or Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Archival tissue (formalin-fixed paraffin-embedded \[FFPE\]) from at least one metastatic site biopsy should be available prior to study enrollment; if archival tissue is not available, then a metastatic site biopsy will be required during the study screening period

Patient must be willing to proceed with an on-treatment biopsy of metastatic site if an on-treatment \[18F\]FTT PET will be performed (at 12 ± 4 weeks after starting PARP inhibitor ± ICI treatment)

For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to \[18F\]FTT PET imaging on day 1. For women who obtain on-treatment (12-week) \[18F\]FTT imaging, a negative serum pregnancy test will be required within 7 days prior to \[18F\]FTT PET imaging

Men and women of reproductive potential need to agree to employ two highly effective and acceptable forms of contraception throughout their participation in the study

Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations

Ability to understand and the willingness to sign a written informed consent document. Informed consent must be provided prior to any study specific procedures

Exclusion

Patients with prior myelodysplastic syndrome or acute myeloid leukemia due to rare risk associated with PARP inhibitor therapy

Pregnant or breastfeeding women

Patient with a known hypersensitivity to the proposed PARP inhibitor product

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of PARP inhibitor therapy (per investigator's discretion)

What this trial measures

Overall response rate (ORR)Baseline up to 6 months
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on poly (ADP-ribose) polymerase (PARP) inhibitor ± immune checkpoint inhibitor (ICI) treatment. Will use a boxplot to illustrate the difference of standard uptake value (SUV)max and SUVmean between responders and non-responders.

Trialytics