NCT01663090

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

4.2 years

First QC Date

July 28, 2012

Last Update Submit

October 14, 2020

Conditions

Soft Tissue Sarcoma

Keywords

Newly diagnosed

Outcome Measures

Primary Outcomes (2)

  • Feasibility and sensitivity of nanoparticle-enhanced MRI

    To determine the feasibility and evaluate the sensitivity of using nanoparticle-enhanced MRI in detecting lymph node metastases in pediatric and adult soft tissue sarcoma patients with clinically palpable or radiographically concerning lymph nodes, whereby the minimum acceptable sensitivity was selected based on a histologic gold standard

    4 years

  • Sensitivity of nanoparticle-enhanced MRI in occult lymph node metastases

    To evaluate the sensitivity of nanoparticle-enhanced MRI in detecting occult lymph node metastases in pediatric and adult patients with soft tissue sarcoma, whereby the minimum acceptable sensitivity was selected based on a histologic gold standard

    4 years

Secondary Outcomes (4)

  • Safety of ferumoxytol in pediatric patients

    4 years

  • Sensitivity of conventional MRI vs. nanoparticle enhanced MRI

    4 years

  • Compare inter-reader variability in the interpretation of nanoparticle MRI scans

    4 years

  • Retrospective central pathology review

    4 years

Study Arms (1)

Nanoparticle enhanced MRI

EXPERIMENTAL
Drug: Ferumoxytol

Interventions

FerumoxytolDRUG
Nanoparticle enhanced MRI

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsFerrous CompoundsMinerals

Study Officials

  • Allison O'Neill, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2012

First Posted

August 13, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

US(4)