Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

The Hospital for Sick Children

Status and phase

Invitation-only

Phase 1

Conditions

Rhabdomyosarcoma

Non-Rhabdo. Soft Tissue Sarcoma

Treatments

Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]

Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI

Diagnostic Test: Diffusion-Weighted [DW] MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03054792

1000049533

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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.