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Trial record 2 of 25 for:    Feridex

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

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ClinicalTrials.gov Identifier: NCT00920023
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ralph Weissleder, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Pancreatic Cancer
Intervention Drug: Superparamagnetic Iron Oxide Magnetic Resonance Imaging
Enrollment 35

Recruitment Details  
Pre-assignment Details  
Arm/Group Title SPIO MRI
Hide Arm/Group Description 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
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title SPIO MRI
Hide Arm/Group Description 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
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
64.8  (13.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
7
  46.7%
Male
8
  53.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
1.Primary Outcome
Title To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
Hide Description 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.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO MRI
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of positive cases
83.3
(36.4 to 99.1)
2.Primary Outcome
Title To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
Hide Description 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.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPIO MRI
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of true negative sample
80
(29.8 to 98.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SPIO MRI
Hide Arm/Group Description 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
All-Cause Mortality
SPIO MRI
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SPIO MRI
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SPIO MRI
Affected / at Risk (%)
Total   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ralph Weissleder
Organization: Massachusetts General Hospital
Phone: 6177268226
Responsible Party: Ralph Weissleder, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00920023     History of Changes
Other Study ID Numbers: 08-085
First Submitted: June 10, 2009
First Posted: June 12, 2009
Results First Submitted: March 21, 2017
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017