Radiation-Free Whole Body MRI for Children With Cancer
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
Recruiting
Phase 1Phase 2Interventional Study
Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 40
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Diagnostic
Participants needed
75 (estimated)
Sponsor
Heike E Daldrup-Link · Other
Who this trial is looking for
This trial is looking for children with certain types of cancer to test a new imaging technique. Participants will undergo whole body MR and PET/MR scans to see how well they can detect the spread of disease without radiation exposure.
Are You a Good Fit for This Trial?
Rules you outHemosiderosisHemochromatosis
You may be able to join if
I have been diagnosed with a solid extra-cranial tumor.
I am scheduled for or have completed a PET or PET/CT tumor staging procedure.
I have not had any restrictions on prior treatment.
You may not be able to join if
I have metal implants that are not compatible with MRI.
I need sedation or feel claustrophobic.
I have a history of allergic reactions to iron compounds or similar drugs.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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 anesth…
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.
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