NCT03418818

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 50 patients enrolled in Arm B will receive pimonidazole approximately 16-20 hours before surgery.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2018Oct 2028

First Submitted

Initial submission to the registry

January 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

10.5 years

First QC Date

January 26, 2018

Last Update Submit

March 3, 2026

Conditions

Sarcoma

Keywords

hypoxiasarcomaFAZAPET Imaging

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Study Arms (2)

Arm A

EXPERIMENTAL

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

Drug: 18F-FAZA

Arm B

EXPERIMENTAL

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.

Drug: Pimonidazole

Interventions

18F-FAZADRUG

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.

Arm A
PimonidazoleDRUG

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.

Arm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, L4W4C2, Canada

Location

MeSH Terms

Conditions

SarcomaHypoxia

Interventions

fluoroazomycin arabinosidepimonidazole

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 1, 2018

Study Start

March 27, 2018

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

CA(1)