Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Oxygen Level Dependent [BOLD] MRI, Diffusion-Weighted [DW] MRI, Magnetic Resonance Spectroscopy [MRS].
- Who it may be relevant to
- Registry conditions: Rhabdomyosarcoma, Non-Rhabdo. Soft Tissue Sarcoma. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
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.
Interventions
- 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
Primary outcome measures
- Number of participants with response to therapy [Time frame: 1 year]
Secondary outcome measures (1)
- Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor. [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- The Hospital for Sick Children — Toronto
Identifiers
NCT: NCT03054792 · 1000049533