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FAZA PET/MRI Sarcoma

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ClinicalTrials.gov Identifier: NCT03418818
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:

This is a single arm, single centre, investigator initiated study to investigate the use of FAZA-PET in combination with MRI. FAZA is an investigational radiotracer used in PET scans. FAZA PET/MRI will be used to measure hypoxia in sarcoma tissues of 14 patients who plan to undergo neoadjuvant radiation/chemotherapy treatment.

After the FAZA PET/MRI scan, patients will be followed up via telephone, 48 hours after the scan, to see if there are any side effects due to FAZA. Patients may also be requested to repeat the FAZA scan after their standard of care radiation treatment.


Condition or disease Intervention/treatment Phase
Sarcoma Drug: 18F-FAZA Not Applicable

Detailed Description:

Mutliple studies show that hypoxia in sarcoma has been consistently associated with poor treatment outcomes. Subsequently, there has been a study that shows inhibition of hypoxia-induced transcription factor (HIF-1 alpha), with radiation, was effective in disease treatment in pre-clinical models. This shows how important hypoxia was in playing a role in overall disease outcome and survival.

As a means of examining tumor features, such as hypoxia, hybrid PET/MR imaging combines the advantages of MRI's soft-tissue and contrast resolution with PET's functional metabolic capabilities. There have been few reports of using 18F-FDG in diagnostic PET/MRI. with the use of 18F-FAZA in this study, parameters such as diffusion, micro-perfusion, and contrast enhancement (as a surrogate marker for viable tumour tissue) can be simultaneously compared with the FAZA-derived pattern, in a single procedure.

The study is being conducted to measure the volume of hypoxic tumor in high-risk STS patients, using FAZA-PET/MRI, before and after neoadjuvant radiotherapy/chemotherapy.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study of Hypoxia Imaging in Patients With Soft Tissue Sarcoma Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA) in Combination With MRI
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: 18F-FAZA
    18F-FAZA is a radiotracer used for PET imaging (in combination with MRI) to detect hypoxia in tumours. This scan will be done before and after their radiation treatment.

Outcome Measures
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Primary Outcome Measures :
  1. Grade of FAZA uptake in the primary tumor [ Time Frame: 2 years ]
    Graded based on images from the 2-hour static scan: 0, uptake less than surrounding normal background tissues; 1, no regions of focal uptake higher than that of background; 2, focal uptake moderately higher than background; and 3, focal uptake markedly higher than background


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients with either: high-risk extremity STS (g2-3, > 10 cm largest dimension, and leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumour, or undifferentiated pleomorphic sarcoma), or: high-risk RPS (g2-3, and leiomyosarcoma or dedifferentiated liposarcoma)
  3. Intention to treat using radiotherapy/chemotherapy/surgery according to the current treatment policies of the Sarcoma Site Group of PM
  4. A negative serum pregnancy test within the two-week interval immediately prior to PET-MR imaging, for women of child-bearing age
  5. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  1. Previous radiotherapy to intended treatment volumes.
  2. Previous systemic therapy
  3. Active malignancy other than sarcoma
  4. Unable to remain supine for at least 60 minutes
  5. Pregnancy or breast feeding
  6. Age less than 18 years old
  7. Failure to provide written informed consent
  8. Contraindication for MR as per current institutional guidelines.
Contacts and Locations
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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): NCT03418818


Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, L4W4C2
Contact: David Shultz, MD    416-946-4501 ext 2127    david.shultz@rmp.uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03418818     History of Changes
Other Study ID Numbers: 17-6178
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
hypoxia
sarcoma
FAZA
PET Imaging
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Fluoroazomycin arabinoside
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action