Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT04306861
Status:
WITHDRAWN
Last Update Posted:
2022-07-21
First Post:
2019-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel MRI Techniques for Pancreatic Cancer
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Study Overview
Official Title:
Novel Multi-parametric MRI Techniques for Assessment of Patients With Pancreatic Ductal Adenocarcinoma Before and During Neoadjuvant Therapy
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment 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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: