A Pilot Study of Diffusion MRI in the Assessment of Pancreatic Tumor Response

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT01209962
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy and chemotherapy, depending on the location of the cancer and other individual patient health factors. The goals of therapy are to reduce or eliminate the cancer cells, but without serious damage to normal cells. Investigators at The University of Michigan are conducting a research project, to see if treatment effects on an individual patient's cancer cells can be detected early by new imaging tests in patients with resectable pancreatic cancer undergoing neoadjuvant chemoradiotherapy.

Detailed Description

Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy and chemotherapy, depending on the location of the cancer and other individual patient health factors. The goals of therapy are to reduce or eliminate the cancer cells, but without serious damage to normal cells.Each patient is unique in terms of the cancer type and location and its sensitivity to treatments. Investigators at The University of Michigan are conducting a research project to see if treatment effects on an individual patient's cancer cells can be detected early by new imaging tests in patients with resectable pancreatic cancer undergoing neoadjuvant chemoradiotherapy. Each patient is unique in terms of the cancer type and location and its sensitivity to treatments.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2010-04-02
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Primary Completion: 2015-05-26
• Study Completion: 2015-05-26
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with histologic or cytologic proof of pancreatic cancer, for whom the treatment plan, at the time of enrollment, is neoadjuvant chemoradiotherapy followed by surgical resection.
• Patients must be >18 years old.
• Patients cannot weight over 300 pounds, the weight limit of the MRI table.
• Patients must have adequate renal function (estimated glomerular filtration rate > 60 mL/min/m2), to minimize the small risk of nephrogenic systemic sclerosis associated with gadolinium injection.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of UM hospital.

Exclusion Criteria

• Patients must have no previous radiation to the abdomen.
• Patients who are pregnant or lactating are excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diffusion MRI	5 years	The goal is to develop a functional imaging method that would be a better predictor of pathological response than the current CT standard. Diffusion MRI has the potential to measure early cellular changes that occur in response to successful therapies, such as chemoradiation, and has been demonstrated to be an early predictor not only of therapeutic response, but also of overall survival for other malignancies.

Secondary Outcome Measures

Name	Time	Method
Apparent Diffusion Coefficient (ADC)	5 years	Demonstrate that the distribution of Apparent Diffusion Coefficient in pancreatic tumors, as measured by diffusion MRI, changes in response to neoadjuvant chemoradiotherapy, and characterize the differences in the distributions between histopathologic responders and non-responders.

Trial Locations

Locations (1)

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States