Back to results

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

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Superparamagnetic Iron Oxide Magnetic Resonance Imaging

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring SPIO MRI, Feridex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPIO MRI

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00920023

First Posted

June 10, 2009

Last Updated

June 26, 2017

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00920023

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

SPIO MRI, Feridex

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SPIO MRI

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Superparamagnetic Iron Oxide Magnetic Resonance Imaging

Other Intervention Name(s)

SPIO MRI, USPIO, Feruoxytol

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

3 years

Title

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

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Weissleder, MD, PhD

Organizational Affiliation

Massachussetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs