Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

Phase 1

• Conditions: Rhabdomyosarcoma; Non-Rhabdo. Soft Tissue Sarcoma
• Interventions: 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]

• Registration Number: NCT03054792
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Study Start: 2017-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAZA - BOLD- DW- MRS	18F-FAZA (F18-Fluoroazomycin Arabinoside)	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 \[MRS\]
FAZA - BOLD- DW- MRS	Blood Oxygen Level Dependent [BOLD] MRI	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 \[MRS\]
FAZA - BOLD- DW- MRS	Diffusion-Weighted [DW] MRI	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 \[MRS\]
FAZA - BOLD- DW- MRS	Magnetic Resonance Spectroscopy [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 \[MRS\]

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.	1 year

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada