Can an imaging tracer help predict if cholangiocarcinoma patients will respond to standard therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial uses [18F]FTT PET/CT imaging before and during treatment to see if PARP1-targeted imaging can forecast response to GCD therapy in newly diagnosed cholangiocarcinoma. Participants receive the tracer IV and undergo PET/CT at specified time points, with standard imaging as part of care. The study follows patients for 24 weeks and up to 6 months after completing therapy to monitor outcomes. The trial is conducted at the Fred Hutch/University of Washington Cancer Consortium in Seattle, led by the University of Washington.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient must have histologically confirmed cholangiocarcinoma
* Patient must be newly diagnosed and have not yet been treated
* Patient planned to receive GCD per standard-of-care
* Patient must have evaluable disease or at least one measurable lesion that can be assessed at baseline by CT (or MRI) per RECIST 1.1
* Age ≥ 18 years
* For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to \[18F\]FTT PET imaging
* Men and women of reproductive potential need to agree to employ acceptable forms of contraception throughout their participation in the study that meet requirements for GCD treatment per standard of care
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing all study procedures
* 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 Criteria:

* Pregnant or breastfeeding women
* 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

Where it's running

• Fred Hutch/University of Washington Cancer Consortium
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Angela Castellanos Rodriguez, MD, MSc — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Angela Castellanos Rodriguez, MD, MSc
• Email: acastell@uw.edu
• Phone: 206-606-6777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.