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


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Diffusion MRI

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Mary Feng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2008.034

NCT ID:

NCT01209962

Start Date:

May 2008

Completion Date:

May 2017

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

University of Michigan Cancer Center Ann Arbor, Michigan  48109