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FAZA PET/MRI Sarcoma

Primary Purpose

Sarcoma

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

18F-FAZA

Pimonidazole

About this trial

This is an interventional diagnostic trial for Sarcoma focused on measuring hypoxia, sarcoma, FAZA, PET Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
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)
Intention to treat using radiotherapy/chemotherapy/surgery according to the current treatment policies of the Sarcoma Site Group of PM
A negative serum pregnancy test within the two-week interval immediately prior to PET-MR imaging, for women of child-bearing age
Ability to provide written informed consent to participate in the study

Exclusion Criteria:

Previous radiotherapy to intended treatment volumes.
Previous systemic therapy
Active malignancy other than sarcoma
Unable to remain supine for at least 60 minutes
Pregnancy or breast feeding
Age less than 18 years old
Failure to provide written informed consent
Contraindication for MR as per current institutional guidelines.

Sites / Locations

University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A

Arm B

Arm Description

Participants will complete FAZA PET/MRI scan and radiation therapy before surgery.

Participants will receive pimonidazole prior to surgery. Participants in Arm B also have the option to complete a FAZA PET/MRI scan prior to surgery.

Outcomes

Primary Outcome Measures

Grade of FAZA uptake in the primary tumor

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03418818

First Posted

January 26, 2018

Last Updated

April 5, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT03418818

Brief Title

FAZA PET/MRI Sarcoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 27, 2018 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a dual 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 and will occur for: Arm A: before neo-adjuvant radiation/chemotherapy treatment; Arm B: before surgery (optional). 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. Up to 20 patients enrolled in Arm B will receive pimonidazole approximately 16-20 hours before surgery.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

Keywords

hypoxia, sarcoma, FAZA, PET Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Participants will complete FAZA PET/MRI scan and radiation therapy before surgery.

Arm Title

Arm B

Arm Type

Experimental

Arm Description

Participants will receive pimonidazole prior to surgery. Participants in Arm B also have the option to complete a FAZA PET/MRI scan prior to surgery.

Intervention Type

Drug

Intervention Name(s)

18F-FAZA

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pimonidazole

Intervention Description

Pimonidazole is a drug that will attached to areas in the tumour that are low in oxygen. When this occurs, the areas of the tumour that are low in oxygen can be more easily found and studied after surgical removal.

Primary Outcome Measure Information:

Title

Grade of FAZA uptake in the primary tumor

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years 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) Intention to treat using radiotherapy/chemotherapy/surgery according to the current treatment policies of the Sarcoma Site Group of PM A negative serum pregnancy test within the two-week interval immediately prior to PET-MR imaging, for women of child-bearing age Ability to provide written informed consent to participate in the study Exclusion Criteria: Previous radiotherapy to intended treatment volumes. Previous systemic therapy Active malignancy other than sarcoma Unable to remain supine for at least 60 minutes Pregnancy or breast feeding Age less than 18 years old Failure to provide written informed consent Contraindication for MR as per current institutional guidelines.

Facility Information:

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

L4W4C2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Shultz, MD

Phone

416-946-4501

Ext

2127

david.shultz@rmp.uhn.ca

12. IPD Sharing Statement

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FAZA PET/MRI Sarcoma

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