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FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)

Study Purpose

GBM represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Each participant must meet all of the following inclusion criteria to participate in this study:
  • - ≥ 18 years of age.
  • - Diagnosis of glioblastoma multiforme.
  • - Post-maximally safe surgical resection.
  • - No prior radiation or systemic treatment for high grade glioma.
  • - Able to tolerate PET/MRI scan with intravenous contrast.
  • - Willing to provide informed consent.

Exclusion Criteria:

All participants meeting any of the following exclusion criteria at baseline screening will be excluded from participation in this study:
  • - MRI contraindication.
  • - Creatinine clearance < 30mL/min.
  • - Inability to lie still for 60 minutes.
  • - Gadolinium allergy.
  • - Positive pregnancy test.
  • - Breastfeeding.
- Patient unable to follow the protocol for any reason

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06451042
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sunnybrook Health Sciences Centre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amit Singnurkar
Principal Investigator Affiliation Sunnybrook Health Sciences Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Additional Details

Please see trial details below:

Arms & Interventions

Arms

: Post-Op GBM PET/MRI

18F-FET PET/MRI for planning of radiation therapy of post-operative glioblastoma multiforme patients

Interventions

Diagnostic Test: - FET-PET/MRI

Radiation planning target volume (PTV) when planned with FET-PET/MRI to PTV when planned with conventional (Standard of Care) MRI only. 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) 180-200 MBq administered intravenously prior to PET/MRI imaging.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5

Site Contact

Amit Singnurkar, MD

[email protected]

416-48-6100 #62064