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Trial record 2 of 24 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SPIO MRI 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

Participant Flow:   Overall Study
    SPIO MRI
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SPIO MRI 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

Baseline Measures
   SPIO MRI 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.8  (13.04) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  46.7% 
Male      8  53.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   15 


  Outcome Measures

1.  Primary:   To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.   [ Time Frame: 3 years ]

2.  Primary:   To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: RWEISSLEDER@MGH.HARVARD.EDU



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