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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01209962
Enrollment
20
Registered
2010-09-27
Start date
2008-05-31
Completion date
2015-05-26
Last updated
2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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.

Interventions

None listed

Sponsors

University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diffusion MRI5 yearsThe 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

MeasureTime frameDescription
Apparent Diffusion Coefficient (ADC)5 yearsDemonstrate 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026