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Completed

NCT Number: NCT00920023

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: SPIO MRI, USPIO, Feruoxytol

Primary outcomes

  1. 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

    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.

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Jun 12, 2009
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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