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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01209962
First received: April 2, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Diffusion MRI in the Assessment of Pancreatic Tumor Response

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Diffusion MRI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • Apparent Diffusion Coefficient (ADC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: May 2008
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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".

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209962

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Mary Feng, MD University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01209962     History of Changes
Other Study ID Numbers: UMCC 2008.034, HUM 20979
Study First Received: April 2, 2010
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014