New radiation-free MRI technique for staging cancer in children
Development of Radiation Free Whole Body MR Imaging Technique for Staging of Children With Cancer.
PHASE1; PHASE2 · Stanford University · NCT01542879
This study is testing a new MRI technique without radiation to see if it can better detect cancer spread in children with solid tumors compared to standard imaging methods.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 6 Years to 40 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT01542879 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel whole body magnetic resonance imaging (MR) technique combined with a new contrast agent, ferumoxytol, to assess the spread of solid tumors in children. It aims to compare the effectiveness of this new imaging method against standard imaging techniques like CT and PET scans. The primary goal is to determine if the new MR technique can provide similar or improved accuracy in detecting cancer spread while significantly reducing radiation exposure. The study includes children diagnosed with solid tumors who are scheduled for conventional imaging procedures.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with solid extra-cranial tumors who are scheduled for standard tumor staging procedures.
Not a fit: Patients with MR-incompatible metal implants, those requiring sedation, or those with a history of allergic reactions to iron compounds may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer imaging option for children with cancer, minimizing their exposure to harmful radiation.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cancer detection, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of a solid extra-cranial tumor like malignant lymphoma or malignant sarcoma and * Scheduled for or completed a 18F-FDG-PET or 18F-FDG-PET/CT tumor staging procedure. * There will be no restrictions on prior treatment. * Very young children who need sedation or anesthesia will be excluded from the study. * In this pediatric \& adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate. Exclusion Criteria: * MR-incompatible metal implants, * need of sedation or claustrophobia. * Hemosiderosis/hemochromatosis (patients can still be included in 2nd branch without ferumoxytol) * There will be restrictions regarding use of other Investigational Agents: Pt with iron-overload will not receive Ferumoxytol * History of allergic reactions to similar compounds will be obtained and patients with a positive history of allergic reaction to iron compounds or other severe allergic reactions.will be excluded from the study. * Pregnant women and fetuses.
Where this trial is running
Stanford, California
- Stanford University Cancer Institute — Stanford, California, United States (RECRUITING)
Study contacts
- Principal investigator: Heike Daldrup-Link — Stanford University
- Study coordinator: Lucia Barrato
- Email: lbaratto@stanford.edu
- Phone: 415 307 1990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer