Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer

Heike E Daldrup-Link

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Cancer

Treatments

Procedure: WB-DW-MR scan

Drug: Ferumoxytol

Procedure: 18-F-FDG PET scan

Procedure: 18-F-FDG PET/MR scan

Study type

Interventional

Funder types

Other

Identifiers

NCT01542879

PEDSVAR0017 (Other Identifier)

IRB-20221 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

75 estimated patients

Sex

All

Ages

6 to 40 years old

Volunteers

No Healthy Volunteers

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.