Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study is a pilot study to evaluate a new contrast agent, ferumoxytol, for the purpose of imaging lymph node metastases in patients with soft tissue sarcoma. This contrast agent is an investigational drug. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved ferumoxytol for this use. This drug has been used to image adults with other forms of cancer, however, it has only been used to image a small number of pediatric patients. Ferumoxytol has never been used to image sarcoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Treatments: Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• New diagnosis of soft tissue sarcoma, who will undergo lymph node biopsy

• Able to tolerate MRI scan without sedation/anesthesia

• Greater than or equal to 12 years of age

Exclusion Criteria:

• Previous therapy other than biopsy or surgical resection of the primary tumor

• Pregnant or breastfeeding

• Receipt of other iron-oxide based nanoparticle therapy within 4 weeks of scans

• History of allergic reaction to compounds of similar composition to ferumoxytol

• Known diagnosis of hemochromatosis, mitochondrial disorder or iron overload

• Invasive bacterial infection

• Known history of contrast sensitivity

• Braces or metal heart valve that may interfere with MRI, surgical clips, a pacemaker, piercings that cannot be removed, or any other indwelling metal device that might interfere with MRI