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Enrolling by Invitation

NCT Number: NCT03054792

Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

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.

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Key information

Conditions

Rhabdomyosarcoma Myosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Non-Rhabdo. Soft Tissue Sarcoma Sarcoma

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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

Primary outcomes

  1. Number of participants with response to therapy

    Time frame: 1 year

    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.

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Feb 16, 2017
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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