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NCT07673341 · ClinicalTrials.gov registry record · Phase 2
[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, sponsored by University of Washington.
- Not yet
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT07673341: Clinical Trial Phase 2 study, sponsored by University of Washington.
NCT07673341 is a Phase 2 study that has not yet begun recruiting, run by University of Washington. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07673341, a Phase 2 study, has not yet begun recruiting, sponsored by University of Washington.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
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 di
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Positron Emission Tomography
- RADIATION Fluorine F 18 Fluorthanatrace
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2026-11-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What is known before NCT07673341 opens enrollment
NCT07673341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Computed Tomography is the first listed.
NCT07673341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07673341 about?
NCT07673341 is a clinical study titled "[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...
What is the current status of trial NCT07673341?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2026-11-01. Estimated completion is 2028-12-31.
What interventions are being tested in trial NCT07673341?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Fluorine F 18 Fluorthanatrace (RADIATION).
Who is sponsoring clinical trial NCT07673341?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07673341's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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