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Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

StatusEnrolling by Invitation
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 2025 to Dec 2026
    • Study completion date: Dec 2025 to Jun 2027
    v8
  2. Primary completion date: Dec 2023 to Jun 2025
    • Study completion date: Dec 2024 to Dec 2025
    • Interventions: 18F-FAZA (F18-Fluoroazomycin Arabinoside) (Drug), Blood Oxygen Level Dependent [BOLD] MRI (Diagnostic Test), Diffusion-Weighted [DW] MRI… to Blood Oxygen Level Dependent [BOLD] MRI (Diagnostic Test), Diffusion-Weighted [DW] MRI (Diagnostic Test), Magnetic Resonance Spectroscopy…
    v7
  3. Primary completion date: Jun 2023 to Dec 2023
    • Study completion date: Dec 2023 to Dec 2024
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Primary completion date: Jun 2020 to Jun 2023
    • Study completion date: Jul 2021 to Dec 2023
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Jun 2019 to Jun 2020
    • Study completion date: Jul 2020 to Jul 2021
    • Start date changed from estimate of Jun 1, 2017 to May 1, 2017
    v3
  2. Start date: Apr 1, 2017 to Jun 1, 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03054792
Lead Sponsor The Hospital for Sick Children
Conditions
(from sponsor)		 Rhabdomyosarcoma, Non-Rhabdo. Soft Tissue Sarcoma
Related terms Rhabdomyosarcoma, Sarcoma
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov