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

NCT ID: NCT01542879

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2026-12-31

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.

Detailed 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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

WB-DW-MR scan

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

Group Type: EXPERIMENTAL

WB-DW-MR scan

Intervention Type: PROCEDURE

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

18-F-FDG PET scan

Intervention Type: PROCEDURE

Ferumoxytol

Intervention Type: DRUG

18-F-FDG PET/MR scan

Intervention Type: PROCEDURE

Interventions

WB-DW-MR scan

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

Intervention Type: PROCEDURE

18-F-FDG PET scan

Intervention Type: PROCEDURE

Ferumoxytol

Intervention Type: DRUG

18-F-FDG PET/MR scan

Intervention Type: PROCEDURE

Other Intervention Names

Whole Body Diffusion Weighted MR scan; Fludeoxyglucose PET scan; feraheme

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 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heike E Daldrup-Link

OTHER

Sponsor Role: lead

Responsible Party

Heike E Daldrup-Link

Associate Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Heike Daldrup-Link

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Cancer Institute

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lucia Barrato

Role: CONTACT

lbaratto@stanford.edu

415 307 1990

Facility Contacts

Lucia Barrato

Role: primary

lbaratto@stanford.edu

415-307-1990

References

Rashidi A, Baratto L, Theruvath AJ, Greene EB, Jayapal P, Hawk KE, Lu R, Seekins J, Spunt SL, Pribnow A, Daldrup-Link HE. Improved Detection of Bone Metastases in Children and Young Adults with Ferumoxytol-enhanced MRI. Radiol Imaging Cancer. 2023 Mar;5(2):e220080. doi: 10.1148/rycan.220080.

Reference Type: DERIVED

PMID: 36999999 (View on PubMed)

Theruvath AJ, Siedek F, Yerneni K, Muehe AM, Spunt SL, Pribnow A, Moseley M, Lu Y, Zhao Q, Gulaka P, Chaudhari A, Daldrup-Link HE. Validation of Deep Learning-based Augmentation for Reduced 18F-FDG Dose for PET/MRI in Children and Young Adults with Lymphoma. Radiol Artif Intell. 2021 Oct 6;3(6):e200232. doi: 10.1148/ryai.2021200232. eCollection 2021 Nov.

Reference Type: DERIVED

PMID: 34870211 (View on PubMed)

Theruvath AJ, Siedek F, Muehe AM, Garcia-Diaz J, Kirchner J, Martin O, Link MP, Spunt S, Pribnow A, Rosenberg J, Herrmann K, Gatidis S, Schafer JF, Moseley M, Umutlu L, Daldrup-Link HE. Therapy Response Assessment of Pediatric Tumors with Whole-Body Diffusion-weighted MRI and FDG PET/MRI. Radiology. 2020 Jul;296(1):143-151. doi: 10.1148/radiol.2020192508. Epub 2020 May 5.

Reference Type: DERIVED

PMID: 32368961 (View on PubMed)

Klenk C, Gawande R, Uslu L, Khurana A, Qiu D, Quon A, Donig J, Rosenberg J, Luna-Fineman S, Moseley M, Daldrup-Link HE. Ionising radiation-free whole-body MRI versus (18)F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre study. Lancet Oncol. 2014 Mar;15(3):275-85. doi: 10.1016/S1470-2045(14)70021-X. Epub 2014 Feb 19.

Reference Type: DERIVED

PMID: 24559803 (View on PubMed)

Other Identifiers

IRB-20221

Identifier Type: OTHER

Identifier Source: secondary_id

PEDSVAR0017

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-20221

Identifier Type: -

Identifier Source: org_study_id