Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
|ClinicalTrials.gov Identifier: NCT03054792|
Recruitment Status : Enrolling by invitation
First Posted : February 16, 2017
Last Update Posted : June 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rhabdomyosarcoma Non-Rhabdo. Soft Tissue Sarcoma||Drug: 18F-FAZA (F18-Fluoroazomycin Arabinoside) Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI Diagnostic Test: Diffusion-Weighted [DW] MRI Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||July 2021|
Experimental: FAZA - BOLD- DW- MRS
18F-FAZA (F18-Fluoroazomycin Arabinoside) is a radioactive agent developed as a non-invasive probe for the assessment of cellular hypoxia. 18F-FAZA Injection is indicated in a single dose of (5.2 MBq/kg [0.14 mCi/kg]) Route/method of administration: intravenous injection.
Blood Oxygen Level Dependent [BOLD], Diffusion-Weighted [DW] MRI, MR Spectroscopy [MRS]
Drug: 18F-FAZA (F18-Fluoroazomycin Arabinoside)
Intravenous administration of a hypoxia marker, 18F- Fluoroazomycin arabinoside (FAZA), before a PET-MR imaging in order to identify areas of lower oxygen content on samples of a tumour.
Other Name: 18F- FAZA
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
- 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 and necrotic areas and 18F-FAZA uptake.
- Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor. [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054792
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|