[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 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
22
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Angela Castellanos Rodriguez, MD, MSc
- Numéro de téléphone: 206-606-6777
- E-mail: acastell@uw.edu
Lieux d'étude
-
-
Washington
-
Seattle, Washington, États-Unis, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
Contact:
- Angela Castellanos Rodriguez, MD, MSc
- Numéro de téléphone: 206-606-6777
- E-mail: acastell@uw.edu
-
Chercheur principal:
- Angela Castellanos Rodriguez, MD, MSc
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Passer une IRM
Autres noms:
Subir une TEP/TDM
Autres noms:
Étant donné IV
Autres noms:
Passer une TEP/TDM et/ou une TDM
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Relationship between standardized uptake value maximum (SUVmax) and overall response rate
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Relationship between standardized uptake value mean (SUVmean) and overall response rate
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Angela Castellanos Rodriguez, MD, MSc, Fred Hutch/University of Washington Cancer Consortium
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 novembre 2026
Achèvement primaire (Estimé)
1 juillet 2028
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
22 juin 2026
Première soumission répondant aux critères de contrôle qualité
22 juin 2026
Première publication (Réel)
29 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RG1126474
- NCI-2026-03509 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- FHIRB0021301 (Autre identifiant: Fred Hutch/University of Washington Cancer Consortium)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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