Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatment superparamagnetic iron oxide magnetic resonance imaging
Phase phase 4
Sponsor Massachusetts General Hospital
Start date July 2008
End date October 2013
Trial size 100 participants
Trial identifier NCT00920023, 08-085

Summary

The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for surgical resection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
To determine the sensitivity and specificity of high resolution magnetic resonance imaging with lymphotrophic superparamagnetic nanoparticles to identify small and otherwise undetectable lymph node metastases.
time frame: 3 years

Secondary Outcomes

Measure
To compare disease-free survival and overall survival intervals for patients whose pre-operative imaging and surgical resection pathology showed no evidence of nodal metastases.
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Locally resectable pancreatic mass present on one or more pre-operative imaging modalities - Must demonstrate no evidence of distant metastases as assessed by chest/abdomen/pelvis CT scan - Deemed eligible for resection with curative intent by a treating surgeon who is listed as an investigator on this study - 18 years of age or older - No uncontrolled serious medical or psychiatric illness - Women of childbearing potential must not be pregnant or lactating Exclusion Criteria: - Known allergy to iron or dextran - Pregnant or lactating - Counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device - Sickle cell disease or hemoglobinopathy

Additional Information

Official title Improved Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)
Principal investigator Ralph Weissleder, MD, PhD
Description - On the first day, study participants will undergo 2 MRI examinations. A scan will be done prior to administration of the contrast agent (Feraheme) and then a second scan immediately after administration. On the second day, study participants will be asked to return for a third MRI. - All MRI scans will be done at Massachusetts General Hospital.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.