Clinical trialObsWithdrawn
Novel MRI Techniques for Pancreatic Cancer
Novel Multi-parametric MRI Techniques for Assessment of Patients With Pancreatic Ductal Adenocarcinoma Before and During Neoadjuvant Therapy
- Outcome
- Stopped earlyEnrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval (Enrollment)
- Phase
- Obs
- Status
- Withdrawn
- Study type
- Observational
- Start
- 9 March 2020
- Expected end
- 30 August 2022
- Enrollment
- 0 participants
- Sites
- 0
- Primary outcomes
- Optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC); Measure the biomarkers obtained with MRI in treatment-naïve patients with biopsy-proven PDAC; Correlate MRI biomarkers with histopathology (the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response).
- Sponsor
- Other
- Results posted
- No
- Last update
- 21 July 2022
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to optimize magnetic resonance imaging (MRI) sequences for imaging pancreatic ductal adenocarcinoma and correlate MRI biomarkers with the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response. This study will test magnetic resonance techniques on FDA approved clinical MRI machines in treatment-naïve patients with biopsy-proven PDAC.
Detailed description public domain (ClinicalTrials.gov)
Specific Aims 1. To optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC): Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI, including low b-values for intravoxel incoherent motion measurements and high b-values for Diffusion Kurtosis analysis). 2. To measure these MRI biomarkers in 20 treatment-naïve patients with biopsy-proven PDAC who have been referred to the Beth Israel Deaconess Medical Center (BIDMC) Pancreatic Cancer Program for neoadjuvant chemo-radiation therapy (CRT). 3. To correlate these MRI biomarkers with histopathology, i.e. the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response. The investigators hypothesize the following: 1. It is feasible to develop dedicated MRI protocols with novel MRI techniques including Arterial Spin Labeling (ASL), Blood Oxygenation Level Dependent (BOLD), Magnetization Transfer (MT), and reduced field-of-view Diffusion Weighted Imaging (DWI), and to develop appropriate evaluation methods. 2. The implementation of these new protocols and evaluation methods in patients with pancreatic ductal adenocarcinoma (PDAC) provide biomarkers which correlate with histology and outcome in treatment-naïve patients. 3. The biomarkers are also predictive of therapy response in patients with PDAC during neoadjuvant chemo-radiation therapy (CRT) and correlate with the expression of the tumor suppressor gene SMAD4.