NCT03054792

Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood Oxygen Level Dependent [BOLD] MRI	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.
DIAGNOSTIC_TEST	Diffusion-Weighted [DW] MRI	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
DIAGNOSTIC_TEST	Magnetic Resonance Spectroscopy [MRS]	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

Timeline

• Start date: 2017-05-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2017-02-16
• Last updated: 2024-12-13

Locations

1 site across 1 country: Canada