PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
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).
Detailed description
The overarching goal of this pilot study is to evaluate the usefulness of a novel Magnetic Resonance Imaging (MRI) approach, which measure properties of tumor microenvironment (i.e. vascularity, fibrosis), to predict PDAC response to neoadjuvant therapy (NAT).
Interventions
DIAGNOSTIC_TEST6D-MRI
Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Persons with allergy to animal dander or animal-instigated asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of progression-free survival from baseline | 2 years | Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging. |
| Number of participants with R0 resection | 2 years | The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery. |
Countries
United States
Outcome results
None listed