NCT01542879 Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
| NCT ID | NCT01542879 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Heike E Daldrup-Link |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2012-02 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 75 participants in total. It began in 2012-02 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body imaging technique and a new MR contrast agent (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a child's disease include magnetic resonance (MR) imaging, computed tomography (CT), Positron Emission Tomography (PET) as well as bone scanning, and metaiodobenzylguanidine (MIBG) scanning. The purpose of this study is to determine if newer imaging tests referred to as whole body diffusion-weighted MR and whole body PET/MR can detect the extent and spread of the disease as accurately or even better as the standard tests (CT, MR and/or PET/CT). The advantage of the new imaging test is that it is associated with no or significantly reduced radiation exposure compared to standard CT and PET/CT imaging tests. The results of whole body MR and PET/MR will be compared with that of the conventional, standard imaging studies for tumor detecting.
Eligibility 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.
Contact & Investigator
Heike Daldrup-Link
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT01542879 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 40 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01542879 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01542879 currently recruiting?
Yes, NCT01542879 is actively recruiting participants. Contact the research team at lbaratto@stanford.edu for enrollment information.
Where is the NCT01542879 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT01542879 clinical trial?
NCT01542879 is sponsored by Heike E Daldrup-Link. The principal investigator is Heike Daldrup-Link at Stanford University. The trial plans to enroll 75 participants.
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