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Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

T

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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