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NCT Number: NCT07673341

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

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location contact

Angela Castellanos Rodriguez, MD, MSc

CONTACT

[email protected]

206-606-6777

Angela Castellanos Rodriguez, MD, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT and/or CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Fluorine F 18 Fluorthanatrace

Radiation

Given IV

Other names: [18F]FluorThanatrace, [18F]FTT, FLUORTHANATRACE F-18

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Positron Emission Tomography

Procedure

Undergo PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Relationship between standardized uptake value mean (SUVmean) and overall response rate

    Time frame: At baseline and 24 weeks after starting GCD

    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.

  2. Change in SUVmax and response

    Time frame: Baseline to 12 weeks after starting GCD

    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.

  3. Change in SUVmean and response

    Time frame: Baseline to 12 weeks after starting GCD

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Castellanos Rodriguez, MD, MSc

CONTACT

[email protected]

206-606-6777

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Imaging PARP Expression in Cholangiocarcinoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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