Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)

Phase 4

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Superparamagnetic Iron Oxide Magnetic Resonance Imaging

• Registration Number: NCT00920023
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2012-02
• Study Completion: 2013-02
• Results First Submitted: 2017-03-21
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Results First Posted: 2017-07-25
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPIO MRI	Superparamagnetic Iron Oxide Magnetic Resonance Imaging	-

Primary Outcome Measures

Name	Time	Method
To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.	3 years	Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive.
To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.	3 years	Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States