Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

Phase 1Enrolling By InvitationNCT03054792

The Hospital for Sick Children18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Rhabdomyosarcoma Non-Rhabdo. Soft Tissue Sarcoma

Interventions

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.

Diffusion-Weighted [DW] MRIDIAGNOSTIC_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

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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