- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03054792
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
April 21, 2023 updated by: Andrea Doria, The Hospital for Sick Children
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
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.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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] |
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 Names:
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.
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
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with response to therapy
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
January 26, 2017
First Submitted That Met QC Criteria
February 13, 2017
First Posted (Actual)
February 16, 2017
Study Record Updates
Last Update Posted (Actual)
April 24, 2023
Last Update Submitted That Met QC Criteria
April 21, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000049533
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No IPD data will be shared with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rhabdomyosarcoma
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Children's Oncology GroupNational Cancer Institute (NCI)RecruitingAlveolar Rhabdomyosarcoma | Embryonal Rhabdomyosarcoma | Botryoid-Type Embryonal Rhabdomyosarcoma | Spindle Cell Rhabdomyosarcoma | Spindle Cell/Sclerosing Rhabdomyosarcoma | Metastatic Embryonal Rhabdomyosarcoma | Metastatic Rhabdomyosarcoma | Solid Alveolar RhabdomyosarcomaUnited States, Canada, Australia, Puerto Rico, Saudi Arabia
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedAdult Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Embryonal-botryoid Childhood Rhabdomyosarcoma | Previously Untreated Childhood RhabdomyosarcomaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Alveolar Childhood Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Previously Untreated Childhood RhabdomyosarcomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Alveolar Childhood Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Previously Untreated Childhood RhabdomyosarcomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Alveolar Childhood Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Embryonal-botryoid Childhood RhabdomyosarcomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Adult Soft Tissue Sarcoma | Adult Rhabdomyosarcoma | Metastatic Childhood Soft Tissue Sarcoma | Childhood Alveolar Rhabdomyosarcoma | Childhood Embryonal Rhabdomyosarcoma | Untreated Childhood RhabdomyosarcomaUnited States, Canada, Australia, New Zealand
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National Cancer Institute (NCI)CompletedRecurrent Childhood Rhabdomyosarcoma | Recurrent Adult Soft Tissue Sarcoma | Previously Treated Childhood Rhabdomyosarcoma | Adult Rhabdomyosarcoma | Childhood Alveolar Rhabdomyosarcoma | Childhood Pleomorphic Rhabdomyosarcoma | Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar FeaturesUnited States, Canada, Australia, New Zealand
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