Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

Sponsor
The Hospital for Sick Children
Study ID
NCT03054792
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Non-Rhabdo. Soft Tissue Sarcoma
  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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.

Key Dates

First listed
Feb 16, 2017
Start date
May 1, 2017
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

Number of participants with response to therapy [ Time Frame: 1 year ]

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