Recruiting
Phase 2

GCD with [18F]FTT

Sponsor:

University of Washington

Code:

NCT07673341

Conditions

Cholangiocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Fluorine F 18 Fluorthanatrace

Magnetic Resonance Imaging

Positron Emission Tomography

Study Details

Brief summary:

This phase II trial studies whether \[18F\]FTT can be used with positron emission tomography (PET)/computed tomography (CT) imaging to predict treatment response in patients scheduled to receive gemcitabine, cisplatin, and durvalumab (GCD) for newly diagnosed cholangiocarcinoma. PET/CT is an imaging technique that utilizes PET and CT in a single machine. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this trial, \[18F\]FTT, to make detailed, computerized pictures of areas inside the body where the tracer is used. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient's body. \[18F\]FTT targets and binds to poly (ADP-ribose) polymerase 1 (PARP1). Some cholangiocarcinoma tumor cells may express PARP1 which may make it easier to see them on PET/CT. Research has shown that tumor cells that express PARP1 may not respond well to GCD treatment. Researchers hope that by using \[18F\]FTT with PET/CT imaging they will be able to detect which patients have tumor cells that express PARP1, which may help predict treatment response in patients scheduled to receive GCD for newly diagnosed cholangiocarcinoma.

Conditions

Cholangiocarcinoma

Study ID

NCT07673341

Start date

Nov 1, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic ([18F]FTT PET/CT)

Patients receive \[18F\]FTT IV and 60, 90, or 150 minutes later undergo PET/CT within 30 days prior to day 1 cycle 1 of GCD and 12 weeks after starting GCD in the absence of unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study.

Interventions

Computed Tomography

Undergo PET/CT and/or CT

Fluorine F 18 Fluorthanatrace

Given IV

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PET/CT

Primary outcome measure

  • Relationship between standardized uptake value maximum (SUVmax) and overall response rate [ Time Frame: At baseline and 24 weeks after starting gemcitabine, cisplatin, and durvalumab (GCD) ]

Central Contacts and Locations

Central contacts

Angela Castellanos Rodriguez, MD, MSc

206-606-6777acastell@uw.edu

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Angela Castellanos Rodriguez, MD, MSc

206-606-6777acastell@uw.edu

Principal Investigator:

Angela Castellanos Rodriguez, MD, MSc

More Information

Sponsor

University of Washington

Last update posted

Sep 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Washington on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.