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

NCT ID: NCT01209962

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2015-05-26

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.

Conditions

Pancreatic Cancer

Study Design

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

Study Groups

Cohort

The majority of recruited patients will be treated on protocol HUM00004531 "A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin with Radiation Therapy in Patients with Pancreatic Cancer".

No interventions assigned to this group

Eligibility Criteria

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.

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

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Cuneo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM 20979

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2008.034

Identifier Type: -

Identifier Source: org_study_id