Clinical trial NCT01209962: A Pilot Study of Diffusion MRI in the Assessment of Pancreatic Tumor Response
Official title: A Pilot Study of Diffusion MRI in the Assessment of Pancreatic Tumor Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2010-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Diffusion MRI
timeFrame: 5 years
Secondary outcomes:
measure: Apparent Diffusion Coefficient (ADC)
timeFrame: 5 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Kyle Cuneo, MD
role: PRINCIPAL_INVESTIGATOR
References: