Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

Rhabdomyosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03054792
• Other study ID #: 1000049533
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: May 1, 2017
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, Magnetic Resonance Spectroscopy (MRS) and 18F-FAZA PET-MRI with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (7-18 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 18
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Non-Rhabdo. Soft Tissue Sarcoma
• Rhabdomyosarcoma
• Sarcoma

Intervention

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.

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.
• 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
• 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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with response to therapy	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.	1 year
Secondary	Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.		1 year