Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01542879

Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer Neoplasms

Age range

6 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University Cancer Institute

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Andrew Quon

SUB_INVESTIGATOR

Anne Muehe

PRINCIPAL_INVESTIGATOR

Dita Gratzinger

SUB_INVESTIGATOR

Florette Kimberley Hazard

SUB_INVESTIGATOR

Heike Daldrup-Link, MD

PRINCIPAL_INVESTIGATOR

Lucia Barrato

CONTACT

[email protected]

415-307-1990

Neyssa Marina

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WB-DW-MR scan

Procedure

WB-DW-MR scans will be obtained on a 3T PET-MR system

Other names: Whole Body Diffusion Weighted MR scan

18-F-FDG PET scan

Procedure

Other names: Fludeoxyglucose PET scan

ferumoxytol

Drug

Other names: feraheme

18-F-FDG PET/MR scan

Procedure

Primary outcomes

  1. Comparison of sensitivity, specificity and accuracy of WB-DW-MR scans to 18-F FDG PET scans.

    Time frame: The outcome will be measured after image acquisition

    To determine sensitivity and specificity for lesion detection on whole-body scans, the body is divided into 10 anatomical regions, and qualified professionals evaluate each region for the presence or absence of tumor lesions. These results are then compared to the gold standard (established through biopsy and follow-up imaging), allowing for the calculation of true positives, false positives, true negatives, and false negatives for each region. Sensitivity and specificity can then be calculated using these values, providing a measure of the scan's accuracy in detecting lesions across different body areas.

Secondary outcomes

  1. Comparison of sensitivity, specificity and accuracy of Ferumoxytol-enhanced whole-body 18-F FDG PET/MR-scans versus standard clinical Gadolinium-enhanced whole-body 18-F FDG PET/MR-scans.

    Time frame: 2 years

    To determine sensitivity and specificity for lesion detection on whole-body scans, the body is divided into 10 anatomical regions, and qualified professionals evaluate each region for the presence or absence of tumor lesions. These results are then compared to the gold standard (established through biopsy or follow-up imaging), allowing for the calculation of true positives, false positives, true negatives, and false negatives for each region. Sensitivity and specificity can then be calculated using these values, providing a measure of the scan's accuracy in detecting lesions across different body areas.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucia Barrato

CONTACT

[email protected]

415 307 1990

Sponsors and collaborators

Lead sponsor

Heike E Daldrup-Link

Other

Registry information

Official study title

Development of Radiation Free Whole Body MR Imaging Technique for Staging of Children With Cancer.

Important dates

Study start
2012
Primary completion
2025
Study completion
2026
First posted
Mar 2, 2012
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.