Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT04700488

Rekrutierung

Magnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)

Interventionsstudie

Phase nicht angegeben

Cedars-Sinai Medical Center

The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients with pancreatic ductal adenocarcinoma (PDAC).

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Diagnostischer Test

Erforderliche Mutationen

Keine

Studie gestartet

2022-05-19

Zuletzt vom Sponsor aktualisiert

2024-10-17

Voraussichtlicher Abschluss

2026-01-01

Eignung

Einschlusskriterien

* Pancreatic cancer patients (with resectable or borderline resectable or locally advanced tumors) who will undergo neoadjuvant chemotherapy

* Patients able to undergo at least two sets of MRI sessions

* Access to a device that has the capability to sync to the Fitbit (or access to a family member's, caregiver's, or friend's device)

Ausschlusskriterien

* Patients who have previously been treated for PDAC

* Patients unable to undergo MRI exam w/contrast

* Patients with metastatic pancreatic cancer visualized on index diagnostic imaging

* Patients with certain metallic implants

* Patients experiencing claustrophobia

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Design-Details

ZuteilungN/A

InterventionsmodellSingle Group Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer36

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: Participants will undergo 6D-MRI imaging three times throughout the course of the study: once pre-NAT treatment, once during NAT treatment, and once post-NAT treatment.

Interventionen:

6D-MRI

Ergebnismessungen

Primäre Ergebnismessungen

Rate of progression-free survival from baseline2 years

Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.

Number of participants with R0 resection2 years

The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.

Change in overall health from baseline, as measured by the Charlson Comorbidity Index (CCI)Baseline, 2 years

Scores are summed depending on the patient's age and the presence of certain comorbidities. Lower scores are correlated to higher overall survival rates.

Change in functional status from baseline, as measured by the Eastern Cooperative Oncology Group (ECOG) Scale of Performance StatusBaseline, 2 years

Scores range from 0 to 4, with 0 denoting fully active and 1-4 for varying degrees of disability.

Sekundäre Ergebnismessungen

Keine

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Studienzentren

Diese Studie hat 1 Studienzentrum

Cedars-Sinai Medical Center
Los Angeles, California, US

Rekrutierend

Los Angeles, California, 90048 US

Cedars-Sinai Medical Center

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