Back to resultsMolecular-Functional Imaging of Hypoxia in Childhood Sarcomas
Primary Purpose
Rhabdomyosarcoma, Non-Rhabdo. Soft Tissue Sarcoma
Status
Enrolling by invitation
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
18F-FAZA (F18-Fluoroazomycin Arabinoside)
Blood Oxygen Level Dependent [BOLD] MRI
Diffusion-Weighted [DW] MRI
Magnetic Resonance Spectroscopy [MRS]
Sponsored by
About this trial
This is an interventional diagnostic trial for Rhabdomyosarcoma
Eligibility 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.
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FAZA - BOLD- DW- MRS
Arm 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]
Outcomes
Primary Outcome Measures
Number of participants with response to therapy
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
Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.
Full Information
NCT ID
NCT03054792
First Posted
January 26, 2017
Last Updated
April 21, 2023
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT03054792
Brief Title
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
Official Title
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhabdomyosarcoma, Non-Rhabdo. Soft Tissue Sarcoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FAZA - BOLD- DW- MRS
Arm Type
Experimental
Arm 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]
Intervention Type
Drug
Intervention Name(s)
18F-FAZA (F18-Fluoroazomycin Arabinoside)
Other Intervention Name(s)
18F- FAZA
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood Oxygen Level Dependent [BOLD] MRI
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diffusion-Weighted [DW] MRI
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Spectroscopy [MRS]
Intervention Description
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 Measure Information:
Title
Number of participants with response to therapy
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD data will be shared with other researchers
Learn more about this trial
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
We'll reach out to this number within 24 hrs