Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

The Hospital for Sick Children

Status and phase: Invitation-only; Phase 1

Conditions: Rhabdomyosarcoma; Non-Rhabdo. Soft Tissue Sarcoma

Treatments: Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI; Drug: 18F-FAZA (F18-Fluoroazomycin Arabinoside); Diagnostic Test: Diffusion-Weighted [DW] MRI; Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]

Study type: Interventional

Funder types: Other

Identifiers

NCT03054792

1000049533

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

FAZA - BOLD- DW- MRS

Experimental group

Description:

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 \[MRS\]

Treatment:

Diagnostic Test: Diffusion-Weighted [DW] MRI

Drug: 18F-FAZA (F18-Fluoroazomycin Arabinoside)

Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]

Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI