Novel MRI Techniques for Pancreatic Cancer

NCT ID: NCT04306861

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2022-08-30

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment Naïve PDAC Patients

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

MRI

Intervention Type: DIAGNOSTIC_TEST

Baseline contrast-enhanced MRI and 2 follow-up contrast-enhanced MRIs (mid-treatment and treatment completion)

Interventions

MRI

Baseline contrast-enhanced MRI and 2 follow-up contrast-enhanced MRIs (mid-treatment and treatment completion)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Leo L Tsai

Assistant Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leo L Tsai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Related Links

http://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html

Key Statistics for Pancreatic Cancer

Other Identifiers

2019-P-000549

Identifier Type: -

Identifier Source: org_study_id