Novel MRI Techniques for Pancreatic Cancer

Novel Multi-parametric MRI Techniques for Assessment of Patients With Pancreatic Ductal Adenocarcinoma Before and During Neoadjuvant Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Diagnostic test: MRI

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy.

Description

Inclusion Criteria:

• Adult male or female patient 18 years of age or older;
• Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC);
• Patient qualifying for neoadjuvant chemo-radiation therapy;
• Patient able and willing to participate in the study;
• Patient must sign the informed consent form in order to participate after the nature of the study has been fully explained to them and any questions they might have are adequately answered.
• eGFR levels greater than or equal to 30 mL/min/1.73m2 before contrast administration.

Exclusion Criteria:

• Patient previously-received or receiving treatment for PDAC at time of enrollment;
• Inability to understand or follow study instructions
• Diagnosed by a nutritionist with severe malnutrition;
• Unintentional weight loss of 20% or more throughout study;
• BMI of < 18.5;
• Patients with a contraindication to MRI examinations will be excluded from this study.
• Pregnancy
• Estimated Glomerular Filtration Rate (eGFR) levels < 30 mL/min/1.73m2

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Naïve PDAC Patients; Patient presenting with treatment-naïve, biopsy-proven pancreatic ductal adenocarcinoma (PDAC) who qualifies for neoadjuvant chemo-radiation therapy.	Diagnostic test: MRI; Baseline contrast-enhanced MRI and 2 follow-up contrast-enhanced MRIs (mid-treatment and treatment completion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Study Duration, an average of 1 year
Measure the biomarkers obtained with MRI in treatment-naïve patients with biopsy-proven PDAC	Biomarkers are obtained from the following imaging methods: 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).	Study Duration, an average of 1 year
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).	Biomarkers are obtained from the following imaging methods: 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).	Study Duration, an average of 1 year

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Leo L Tsai, MD, PhD, Beth Israel Deaconess Medical Center

Publications and helpful links

Helpful Links

• Key Statistics for Pancreatic Cancer

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Imaging; Pancreatic Cancer; PDAC
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 2019-P-000549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No