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AzTrials

CholangiocarcinomaPhase 2NCT07673341

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

A Phase 2 study testing Computed Tomography, Fluorine F 18 Fluorthanatrace and Magnetic Resonance Imaging in people with Cholangiocarcinoma, run by University of Washington at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma
What is being tested?
Computed Tomography, Fluorine F 18 Fluorthanatrace and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
8 Oct 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Angela Castellanos Rodriguez, MD, MSc contact

206-606-6777

acastell@uw.edu

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Angela Castellanos Rodriguez, MD, MSc, 206-606-6777, acastell@uw.edu

    Angela Castellanos Rodriguez, MD, MSc

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Computed Tomography, Fluorine F 18 Fluorthanatrace, Magnetic Resonance Imaging, Positron Emission Tomography
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT and/or CT

  • Fluorine F 18 FluorthanatraceRadiation

    Also called [18F]FluorThanatrace, [18F]FTT, FLUORTHANATRACE F-18

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT07673341
Study groupRoleWhat they receive
Diagnostic ([18F]FTT PET/CT)ExperimentalPatients 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.
Receives: Procedure: Computed Tomography; Radiation: Fluorine F 18 Fluorthanatrace; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and 24 weeks after starting gemcitabine, cisplatin, and durvalumab (GCD)

Secondary outcomes (3)

  1. 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.

    Measured: At baseline and 24 weeks after starting GCD

  2. 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.

    Measured: Baseline to 12 weeks after starting GCD

  3. 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.

    Measured: Baseline to 12 weeks after starting GCD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study start8 Oct 2026
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07673341
Sponsor's protocol ID
RG1126474
Other IDs
NCI-2026-03509, FHIRB0021301
Status last verified
Jun 2026
First submitted
22 Jun 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Fluorine F 18 Fluorthanatrace and Magnetic Resonance Imaging in people with Cholangiocarcinoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angela Castellanos Rodriguez, MD, MSc (206-606-6777, acastell@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07673341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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