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Novel MRI Techniques for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT04306861
Recruitment Status : Suspended (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)
First Posted : March 13, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment
Pancreatic Ductal Adenocarcinoma 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Multi-parametric MRI Techniques for Assessment of Patients With Pancreatic Ductal Adenocarcinoma Before and During Neoadjuvant Therapy
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Optimize the following multiparametric MRI sequences for imaging of Pancreatic ductal adenocarcinoma (PDAC) [ Time Frame: Study Duration, an average of 1 year ]
    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. Measure the biomarkers obtained with MRI in treatment-naïve patients with biopsy-proven PDAC [ Time Frame: Study Duration, an average of 1 year ]
    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).

  3. 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). [ Time Frame: Study Duration, an average of 1 year ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306861


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Leo L Tsai, MD, PhD Beth Israel Deaconess Medical Center
Study Director: Khoschy Schawkat, MD Beth Israel Deaconess Medical Center
Additional Information:
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04306861    
Other Study ID Numbers: 2019-P-000549
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beth Israel Deaconess Medical Center:
Imaging
MRI
PDAC
Pancreatic Cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms