ClinicalTrials.gg
Active, not recruitingNCT03418818Updated Aug 10, 2026

FAZA PET/MRI Sarcoma

An interventional study of 18F-FAZA and Pimonidazole in Sarcoma, sponsored by University Health Network, Toronto. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Sarcoma by University Health Network, Toronto — 7 open to participants now, 8 under way, none of them phase 3. Sarcoma · University Health Network, Toronto.

Planned enrollment
3rd of 16
70 · median 36
Started
2018
the only one that year
No phase
5 of 18
2 open now
Registered
9th of 18
by date

Among the 18 studies in Sarcoma by University Health Network, Toronto, this one is the 3rd largest by planned enrollment of the 16 interventional ones that give a count, is the only one that started in 2018, is one of 5 with no phase, and was the 9th registered.

Sarcoma

1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.

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Open to participants now

7 of the 18 studies in Sarcoma by University Health Network, Toronto are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 301 Sarcoma studies recruiting now, 191 (63%) set no upper age limit and 83 (28%) stop at 75 or younger; 91 take children under 18; 12 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Sarcoma

Keywords

  • hypoxia
  • sarcoma
  • FAZA
  • PET Imaging
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Previous radiotherapy to intended treatment volumes.
  2. Previous systemic therapy
  3. Active 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
  8. for MR as per current institutional guidelines.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Arm A

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

    Drug: 18F-FAZA

  • Experimental
    Arm B

    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-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.

  • 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.

06

What researchers measure

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

    Time frame: 2 years

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Oct 2028, 127 months after the start.

Of 144 non-industry interventional studies with no phase under Sarcoma, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 120. This study's planned 127 months is above that.

Counting every sponsor, half of 147 studies reached it within 59 months; a quarter within 34 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 1, 2018
StartActual
Mar 27, 2018
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2028
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03418818
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
Mar 27, 2018
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Aug 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Fluoroazomycin arabinoside · Pimonidazole

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