[18F]FTT Positron Emission Tomography/Computed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma

Imaging PARP Expression in Cholangiocarcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Radiation: Fluorine F 18 Fluorthanatrace; Procedure: Computed Tomography

Detailed Description

OUTLINE:

Patients receive [18F]FTT intravenously (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 magnetic resonance imaging (MRI) throughout the study.

After completion of study intervention, patients are followed up at week 24 and then up to 6 months after completing GCD treatment.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Angela Castellanos Rodriguez, MD, MSc; Phone Number: 206-606-6777; Email: acastell@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Angela Castellanos Rodriguez, MD, MSc; Phone Number: 206-606-6777; Email: acastell@uw.edu
      • Principal Investigator: Angela Castellanos Rodriguez, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Procedure: Positron Emission Tomography; Undergo PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; PT; Positron emission tomography (procedure); Radiation: Fluorine F 18 Fluorthanatrace; Given IV; Other Names: [18F]FluorThanatrace; [18F]FTT; FLUORTHANATRACE F-18; Procedure: Computed Tomography; Undergo PET/CT and/or CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Computerized axial tomography (procedure); Computerized Tomography (CT) scan; Diagnostic CAT Scan; Diagnostic CAT Scan Service Type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between standardized uptake value maximum (SUVmax) and overall response rate	Baseline SUVmax will be extracted from a region of interest (ROI) placed on the tumor lesion of interest using a 40% threshold. Will assess overall response rate at 24 ± 2 weeks after starting GCD by using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Response will be analyzed as a binary outcome. Differences in baseline SUVmax between responders and non-responders will be evaluated using the Wilcoxon rank-sum test. Logistic regression models will be used to estimate the direction and magnitude of association, with response as the dependent variable and SUVmax as the predictor. Odds ratios and 95% confidence intervals will be reported. Analysis will focus on estimation of effect sizes and the direction and magnitude of associations of the primary endpoints, overall response rate and SUVmax of the most avid lesion, rather than formal hypothesis testing alone. Boxplots will be used to visualize the distribution of SUVmax by responders group.	At baseline and 24 weeks after starting gemcitabine, cisplatin, and durvalumab (GCD)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between standardized uptake value mean (SUVmean) and overall response rate	Will measure baseline SUVmean from an ROI placed on the tumor lesion of interest using a 40% threshold. Treatment response will be defined by RECIST 1.1 criteria at 24 ± 2 weeks following GCD treatment. Association between baseline SUVmean and treatment response will be evaluated using Wilcoxon rank-sum test. Logistic regression will be used to quantify the magnitude and direction of association between baseline SUVmean and response. Results will be summarized using odds ratios with 95% confidence intervals, and boxplot to illustrate the distribution of baseline SUVmean between responders and non-responders.	At baseline and 24 weeks after starting GCD
Change in SUVmax and response	Will calculate the change of SUVmax from baseline to 12 ± 2 weeks after starting GCD. Due to the limited sample size, will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference in change between responders and non-responders. Effect sizes will be summarized using the median difference (Hodges-Lehmann estimator) in change between groups with 95% confidence intervals.	Baseline to 12 weeks after starting GCD
Change in SUVmean and response	Will calculate the change of SUVmean from baseline to 12 ± 2 weeks after starting GCD. Due to the limited sample size, will use the nonparametric method Wilcoxon Rank Sum test to evaluate the difference in change between responders and non-responders. Effect sizes will be summarized using the median difference (Hodges-Lehmann estimator) in change between groups with 95% confidence intervals.	Baseline to 12 weeks after starting GCD

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Angela Castellanos Rodriguez, MD, MSc, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: RG1126474; NCI-2026-03509 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No