Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

NCT03054792 | Enrolling By Invitation Phase 1

• 1 other identifier: 1000049533
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI and Magnetic Resonance Spectroscopy (MRS) with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.

Conditions

Rhabdomyosarcoma; Non-Rhabdo. Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with response to therapy

  Response will be assessed by measurements of tumor volume, percentage of BOLD signal changes, percentage of tumor necrosis, apparent diffusion coefficient, concentration of high-energy and low-energy phosphates in tumor.

  1 year

Secondary Outcomes (1)

• Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.

  1 year

Study Arms (1)

BOLD- DW- MRS

EXPERIMENTAL

Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI, MR Spectroscopy \[MRS\]

Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI; Diagnostic Test: Diffusion-Weighted [DW] MRI; Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]

Interventions

Blood Oxygen Level Dependent [BOLD] MRI DIAGNOSTIC_TEST

BOLD is a non-invasive T2\*-weighted MRI technique that is sensitive to the microvascular deoxyhemoglobin concentration. BOLD has the potential to monitor changes in tissue oxygenation in response to a gas breathing challenge to induce contrast.

BOLD- DW- MRS

Diffusion-Weighted [DW] MRI DIAGNOSTIC_TEST

DW MRI is a non-invasive technique that provides quantitative biophysical information about the movement of water in tissues and reflects the anisotropy of normal and pathologic cells

BOLD- DW- MRS

Magnetic Resonance Spectroscopy [MRS] DIAGNOSTIC_TEST

MRS is a non-invasive imaging technique that enables the generation of spectral profiles of low molecular weight metabolites that reflect status of a tissue

BOLD- DW- MRS

Eligibility Criteria

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

You may qualify if:

• Referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma \[RMS\] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component;
• Candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy

You may not qualify if:

• Patients with general contraindications for an MRI scan (metal foreign body, pacemaker, inability to tolerate an examination without sedation);
• Patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy;
• Patients with no clinical indication for neoadjuvant therapy prior to surgery;
• Patients with chronic pulmonary disease;
• Patients with other diagnosis confirmed after initial suspicion of RMS or non-RMS.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Rhabdomyosarcoma; Sarcoma

Interventions

Magnetic Resonance Imaging; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Image Enhancement; Photography; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist, Scientist, Research Director

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 16, 2017
• Study Start: May 1, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)