Recruiting
Phase 1
Phase 2

MR Imaging

Sponsor:

Heike E Daldrup-Link

Code:

NCT01542879

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 6 - 40

Healthy Volunteers: Not accepted

Interventions

WB-DW-MR scan

18-F-FDG PET scan

Ferumoxytol

18-F-FDG PET/MR scan

Study Details

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.

Conditions

Cancer

Study ID

NCT01542879

Start date

Feb, 2012

Status verified date

Nov, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 40

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: WB-DW-MR scan

simultaneous WB-DW-MR scan and 18-F FDG PET scan

Interventions

WB-DW-MR scan

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

18-F-FDG PET scan

Ferumoxytol

18-F-FDG PET/MR scan

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Lucia Barrato

415 307 1990lbaratto@stanford.edu

Locations

Stanford University Cancer Institute

Recruiting

Stanford, California, United States, 94305

Contacts

Lucia Barrato

415-307-1990lbaratto@stanford.edu

Principal Investigator:

Heike Daldrup-Link, MD

More Information

Sponsor

Heike E Daldrup-Link

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Heike E Daldrup-Link on 2024-11-25.