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

NCT01209962 | Completed DMC

• 2 other identifiers: UMCC 2008.034HUM 20979
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Diffusion MRI

  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.

  5 years

Secondary Outcomes (1)

• Apparent Diffusion Coefficient (ADC)

  5 years

Study Arms (1)

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".

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Kyle Cuneo, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: September 27, 2010
• Study Start: May 1, 2008
• Primary Completion: May 26, 2015
• Study Completion: May 26, 2015
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

US (1)