Non-Rhabdo. Soft Tissue Sarcoma, Rhabdomyosarcoma
Conditions
Brief summary
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_TESTBlood 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_TESTDiffusion-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_TESTMagnetic 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
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with response to therapy | 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
| Measure | Time frame |
|---|---|
| Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor. | 1 year |
Countries
Canada
Outcome results
None listed