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

NCT00920023 | Completed Phase 4 Results DMC

• 1 other identifier: 08-085
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

SPIO MRI; Feridex

Outcome Measures

Primary Outcomes (2)

• To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.

  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.

  3 years

• To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.

  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.

  3 years

Study Arms (1)

SPIO MRI

EXPERIMENTAL

Drug: Superparamagnetic Iron Oxide Magnetic Resonance Imaging

Interventions

Superparamagnetic Iron Oxide Magnetic Resonance Imaging DRUG

Two MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol

Also known as: SPIO MRI, USPIO, Feruoxytol

SPIO MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• No uncontrolled serious medical or psychiatric illness
• Women of childbearing potential must not be pregnant or lactating

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

ferumoxtran-10

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Ralph Weissleder
• Organization: Massachusetts General Hospital

RWEISSLEDER@MGH.HARVARD.EDU

6177268226

Study Officials

• Ralph Weissleder, MD, PhD

  Massachussetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 12, 2009
• Study Start: July 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2013
• Last Updated: July 25, 2017
• Results First Posted: July 25, 2017

Record last verified: 2017-06

Locations

US (1)