Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 6 - 40 |
| Updated: | 3/6/2019 |
| Start Date: | February 2012 |
| End Date: | July 2019 |
| Contact: | Anne Muehe |
| Email: | amuehe@stanford.edu |
| Phone: | 650-720-8601 |
Development of Radiation Free Whole Body MR Imaging Technique for Staging of Children With Cancer.
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.
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.
Primary Objective: To compare the sensitivity, specificity and accuracy of WB-DW-MR scans
(new technique) with 18F- FDG PET or 18F- FDG PET/CT or 18F- FDG PET/MR scans.
(new technique) with 18F- FDG PET or 18F- FDG PET/CT or 18F- FDG PET/MR scans.
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.
We found this trial at
1
site
875 Blake Wilbur Dr
Stanford, California 94305
Stanford, California 94305
(650) 498-6000
Principal Investigator: Heike Daldrup-Link, MD
Phone: 650-725-8198
Stanford University Cancer Institute The Stanford Cancer Institute (SCI) focuses the world-class expertise of more...
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