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Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054792
Recruitment Status : Enrolling by invitation
First Posted : February 16, 2017
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Doria, 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, 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.

Condition or disease Intervention/treatment Phase
Rhabdomyosarcoma Non-Rhabdo. Soft Tissue Sarcoma 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] Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FAZA - BOLD- DW- 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]

Drug: 18F-FAZA (F18-Fluoroazomycin Arabinoside)
Intravenous administration of a hypoxia marker, 18F- Fluoroazomycin arabinoside (FAZA), before a PET-MR imaging in order to identify areas of lower oxygen content on samples of a tumour.
Other Name: 18F- FAZA

Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI
BOLD is a non-invasive T2*-weighted MRI technique that is sensitive to the microvascular deoxyhemoglobin concentration. BOLD has the potential to monitor changes in tissue oxygenation in response to a gas breathing challenge to induce contrast.

Diagnostic Test: Diffusion-Weighted [DW] MRI
DW MRI is a non-invasive technique that provides quantitative biophysical information about the movement of water in tissues and reflects the anisotropy of normal and pathologic cells

Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]
MRS is a non-invasive imaging technique that enables the generation of spectral profiles of low molecular weight metabolites that reflect status of a tissue




Primary Outcome Measures :
  1. Number of participants with response to therapy [ Time Frame: 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 and necrotic areas and 18F-FAZA uptake.


Secondary Outcome Measures :
  1. Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor. [ Time Frame: 1 year ]


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054792


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
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Responsible Party: Andrea Doria, Radiologist, Scientist, Research Director, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03054792    
Other Study ID Numbers: 1000049533
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD data will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Rhabdomyosarcoma
Hypoxia
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Signs and Symptoms, Respiratory
Myosarcoma
Neoplasms, Muscle Tissue
Fluoroazomycin arabinoside
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action