Overview
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2023-12-01
2023-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The Hospital for Sick ChildrenTreatments:
Fluoroazomycin arabinoside
Criteria
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.