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

NCT01542879 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-20221PEDSVAR0017
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  The outcome will be measured after image acquisition

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.

  2 years

Study Arms (1)

WB-DW-MR scan

EXPERIMENTAL

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

Procedure: WB-DW-MR scan; Procedure: 18-F-FDG PET scan; Drug: Ferumoxytol; Procedure: 18-F-FDG PET/MR scan

Interventions

WB-DW-MR scan PROCEDURE

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

Also known as: Whole Body Diffusion Weighted MR scan

WB-DW-MR scan

18-F-FDG PET scan PROCEDURE

Also known as: Fludeoxyglucose PET scan

WB-DW-MR scan

Ferumoxytol DRUG

Also known as: feraheme

WB-DW-MR scan

18-F-FDG PET/MR scan PROCEDURE

WB-DW-MR scan

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heike E Daldrup-Link: lead

Study Sites (1)

Stanford University Cancer Institute

Stanford, California, 94305, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 36999999 DERIVED

• 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.

  PMID: 34870211 DERIVED

• 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.

  PMID: 32368961 DERIVED

• 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.

  PMID: 24559803 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Ferrosoferric Oxide

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Heike Daldrup-Link

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Barrato

CONTACT

415 307 1990; lbaratto@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 2, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)