Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT04700488

Reclutamiento

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

Intervencionista

Fase no especificada

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).

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Categoría de tratamiento

Prueba diagnóstica

Erforderliche Mutationen

Ninguna

Ensayo iniciado

2022-05-19

Última actualización por el patrocinador

2024-10-17

Finalización estimada

2026-01-01

Elegibilidad

Criterios de inclusión

* 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)

Criterios de exclusión

* 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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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir36

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: 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.

Intervenciones:

6D-MRI

Medidas de resultado

Medidas de resultado primarias

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.

Medidas de resultado secundarias

Ninguno

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

Cedars-Sinai Medical Center
Los Angeles, California, US

Reclutando

Los Angeles, California, 90048 US

Cedars-Sinai Medical Center

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