Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Brief Summary
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Detailed Description
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Conditions
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Interventions
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18F-Floretyrosine
Single IV administration on Day 0, followed by a PET/CT or PET/MR diagnostic scan 20-40 minutes after the IV administration of 18F-Floretyrosine.
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Years
ALL
No
Sponsors
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Telix Pharmaceuticals (Innovations) Pty Limited
INDUSTRY
Responsible Party
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Locations
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CU Anschutz / University of Colorado
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins Baltimore
Baltimore, Maryland, United States
Kettering Health Main Campus
Kettering, Ohio, United States
University Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University Wisconsin Madison
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18F-TLX101-CDX-002
Identifier Type: -
Identifier Source: org_study_id
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