Clinical trial · Interventional
Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas
Ferumoxytol-Enhanced Magnetic Resonance Imaging (MRI) in Pediatric and Adult Patients With Malignant Sarcoma: A Two-part Pilot Study for Safety and Efficacy in the Pediatric and Adult Populations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inability to accrue.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferumoxytol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nanoparticle enhanced MRI
- interventionNames
- Drug: Ferumoxytol
Primary outcomes (2)
- measure
- Feasibility and sensitivity of nanoparticle-enhanced MRI
- timeFrame
- 4 years
- description
- 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
- measure
- Sensitivity of nanoparticle-enhanced MRI in occult lymph node metastases
- timeFrame
- 4 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available