22 Participants NeededMy employer runs this trial

PET/CT Imaging for Bile Duct Cancer

AC
Overseen ByAngela Castellanos Rodriguez, MD, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Washington
Must be taking: Gemcitabine, Cisplatin, Durvalumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new method to predict treatment effectiveness for individuals with newly diagnosed bile duct cancer, also known as cholangiocarcinoma. The study employs a special imaging technique called PET/CT, combined with a radioactive tracer called [18F]FTT, to determine if it can identify cancer cells that may not respond well to the standard treatment of gemcitabine, cisplatin, and durvalumab (GCD). Success in this approach could enable doctors to tailor treatments based on the visibility of these cells in the images. Individuals with newly diagnosed bile duct cancer who plan to start GCD treatment and have at least one measurable tumor may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that PET/CT imaging with [18F]FTT is safe for patients with bile duct cancer?

In previous studies, [18F]FTT has been used in PET scans to locate cancer cells. Research shows it can detect a protein called PARP1 in cancers such as ovarian and breast cancer, aiding doctors in identifying cancer cells.

Safety information on [18F]FTT indicates it is generally well-tolerated. The procedure uses small amounts of radioactivity, similar to other PET scan tracers, and is usually safe with few side effects. Patients in earlier studies did not report any major safety issues. While minor side effects might occur, these are not well-documented in the available studies.

Since this is a Phase 2 trial, earlier phases have demonstrated that the treatment is safe enough for more patients. However, more data is being collected to better understand its safety.12345

Why are researchers excited about this trial?

Researchers are excited about [18F]FTT PET/CT imaging for bile duct cancer because it offers a new way to visualize the cancer with potentially greater precision. Unlike standard imaging techniques, [18F]FTT targets specific cancer cells, allowing for clearer and more accurate images. This could lead to better treatment planning and monitoring, which is crucial for a cancer as challenging to treat as bile duct cancer. By improving the accuracy of imaging, this technique may help doctors tailor treatments more effectively, potentially improving outcomes for patients.

What evidence suggests that PET/CT imaging is effective for predicting treatment response in bile duct cancer?

Research has shown that PET/CT scans using \[18F\]FTT can detect specific cancer markers in cholangiocarcinoma, a type of bile duct cancer. In this trial, participants will receive \[18F\]FTT as part of the diagnostic PET/CT imaging. \[18F\]FTT targets PARP1, a protein sometimes present in these tumors. Studies have found that identifying PARP1 can help pinpoint tumors that might not respond well to common treatments like gemcitabine, cisplatin, and durvalumab. PET/CT accurately identifies individuals without the disease, making it a valuable tool for distinguishing certain tumor cell types. This imaging method could help doctors better predict and understand patient responses to treatment.678910

Who Is on the Research Team?

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Angela Castellanos Rodriguez, MD, MSc

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed intrahepatic cholangiocarcinoma (a type of bile duct cancer) who are about to start treatment with gemcitabine, cisplatin, and durvalumab. Participants should be healthy enough for imaging scans and chemotherapy.

Inclusion Criteria

I am 18 years old or older.
For women of childbearing potential, a negative serum pregnancy test is required within 7 days prior to [18F]FTT PET imaging
Patient is willing and able to comply with the protocol for the duration of the study including undergoing all study procedures
See 6 more

Exclusion Criteria

I am currently pregnant or breastfeeding.
I do not have any uncontrolled illnesses or conditions that would prevent me from following study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants receive [18F]FTT IV and undergo PET/CT imaging to assess PARP1 expression

Within 30 days prior to day 1 cycle 1 of GCD
1 visit (in-person)

Treatment

Participants receive gemcitabine, cisplatin, and durvalumab (GCD) treatment

12 weeks
Regular visits for treatment administration

Follow-up Imaging

Participants undergo PET/CT imaging to evaluate treatment response

12 weeks after starting GCD
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 months after completing GCD treatment
Follow-up visits at week 24 and up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • [18F]FTT

Trial Overview

The study tests if a special PET/CT scan using [18F]FTT can predict how well patients will respond to standard chemo-immunotherapy (gemcitabine, cisplatin, and durvalumab). MRI may also be used. The goal is to see if the scan can help guide future treatment decisions.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Diagnostic ([18F]FTT PET/CT)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Citations

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Its overall prognosis is poor, with 5-year survival rate of less than 5% [1, 2]. The incidence of GBC shows geographic variation, varying from ...

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PET/CT detected nodal involvement in 21 patients (53.8%) and distant metastases in 35 patients (89.7%).

Pancreatic (GI)

Researchers believe that [18F]FAPI more effectively than approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body.

FDG-PET is useful for prediction of lymph node metastasis, P- ...

Fluorine-18 fluorodeoxyglucose positron emission tomography predicts lymph node metastasis, P-glycoprotein expression, and recurrence after resection in mass- ...

A registered clinical trial is examining whether [18F]FTT ...

The study focuses on imaging. Results could support more precise allocation of systemic therapy in biliary tract cancers.

Study Details | NCT06502691 | [18F]FTT Positron Emission ...

Combining [18F]FTT with a PET scan may help detect tumor cells better in patients with metastatic breast cancer who are receiving standard of care PARP ...

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP ... - PMC

[18F]FTT as a biomarker of response to PARPi in ovarian cancer. PET radiotracer [18F]FluorThanatrace ([18F]FTT) measures PARP-1 expression in ovarian cancer.

The Effect of [18F] F-FAPI PET-CT on Management in Patients ...

Possible metastases of the cancer will have to be confirmed when suspicious findings are seen on FAPI PET-CT. This could mean that participants ...

A PET Radiotracer for Imaging Poly (ADP-Ribose) ...

18F-FTT as an imaging-based biomarker for measuring PARP-1 expression levels in patients with breast and ovarian cancer.

[18F]FTT Positron Emission Tomography/Computed ...

18F-FTT is used to create pictures or images of areas that might have PARP-1 activity from the pancreatic neuroendocrine tumor and can be seen on PET.