New brain scan agent helps tell tumor from treatment side effects
NCT ID NCT06743100
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This program gave patients with glioma (a type of brain tumor) access to a special imaging agent called 18F-FET. It was used with PET scans to help doctors tell the difference between actual tumor growth and changes caused by previous treatments. The goal was to improve treatment decisions for patients aged 3 and older with unclear MRI results.
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Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written and voluntarily given informed consent. Pediatric patients (\<18 years of age) will provide assent along with parental/legal guardian /caregiver consent according to IRB requirements. 2. Male or female ≥ 3 years of age at time of consent/assent 3. Diagnosis or clinical suspicion of glioma (any grade) in the brain 4. At the time of screening have undergone therapy for glioma 5. Indeterminate MR findings for disease recurrence or progression versus treatment related changes (pseudoprogression or pseudoresponse) requiring further diagnostic procedures within 60 days prior to the 18F-Floretyrosine PET imaging 6. Willing and able to lie still for at least 40 minutes in an enclosed space for the imaging procedure, or if medically necessary, able to tolerate standard institutions procedures for sedation and/or anesthesia. Exclusion Criteria: 1. Participant cannot be safely scanned due to devices, implants, foreign and/or metallic objects in or on the body that are not MR compatible, unless a clinical judgement is made that the participant's diagnostic needs can instead be met by diversion to 18F-Floretyrosine imaging by PET/CT (making the magnetic field compatibility an irrelevant safety concern). 2. Women who are pregnant or breastfeeding. 3. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of the program (Day 0 to Day 2). 4. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the participant, as judged by the Investigator. 5. Mental impairment that may compromise the ability to give informed consent/assent and comply with the requirements of the program as judged by the Investigator. 6. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date planned administration of 18F-Floretyrosine. 7. Known hypersensitivity to floretyrosine or tyrosine derivatives. 8. Unable to tolerate the program procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CU Anschutz / University of Colorado
Aurora, Colorado, 80045, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Johns Hopkins Baltimore
Baltimore, Maryland, 21205, United States
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Kettering Health Main Campus
Kettering, Ohio, 45429, United States
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MSKCC (Memorial Sloan Kettering Cancer Center)
New York, New York, 10065, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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UC Irvine
Orange, California, 92868, United States
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University Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University Wisconsin Madison
Madison, Wisconsin, 53705-2275, United States
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