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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00920023
• Other study ID #: 08-085
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 10, 2009
• Last updated: March 19, 2013
• Start date: July 2008
• Est. completion date: October 2013

Study information

• Verified date: March 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Superparamagnetic Iron Oxide Magnetic Resonance Imaging
Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 years	Yes
Secondary	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.		3 years	No