[18F]FTT Positron Emission Tomography/Computed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma
12. august 2026 oppdatert av: University of Washington
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
22
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Angela Castellanos Rodriguez, MD, MSc
- Telefonnummer: 206-606-6777
- E-post: acastell@uw.edu
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
Ta kontakt med:
- Angela Castellanos Rodriguez, MD, MSc
- Telefonnummer: 206-606-6777
- E-post: acastell@uw.edu
-
Hovedetterforsker:
- Angela Castellanos Rodriguez, MD, MSc
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Gjennomgå MR
Andre navn:
Gjennomgå PET/CT
Andre navn:
Gitt IV
Andre navn:
Gjennomgå PET/CT og/eller CT
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Relationship between standardized uptake value maximum (SUVmax) and overall response rate
Tidsramme: 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.
|
At baseline and 24 weeks after starting gemcitabine, cisplatin, and durvalumab (GCD)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Relationship between standardized uptake value mean (SUVmean) and overall response rate
Tidsramme: 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.
|
At baseline and 24 weeks after starting GCD
|
|
Change in SUVmax and response
Tidsramme: 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.
|
Baseline to 12 weeks after starting GCD
|
|
Change in SUVmean and response
Tidsramme: 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.
|
Baseline to 12 weeks after starting GCD
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Angela Castellanos Rodriguez, MD, MSc, Fred Hutch/University of Washington Cancer Consortium
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. november 2026
Primær fullføring (Antatt)
1. juli 2028
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
22. juni 2026
Først innsendt som oppfylte QC-kriteriene
22. juni 2026
Først lagt ut (Faktiske)
29. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. august 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RG1126474
- NCI-2026-03509 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- FHIRB0021301 (Annen identifikator: Fred Hutch/University of Washington Cancer Consortium)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .