18F-Floretyrosine Expanded Access Program

Get Involved

18F-Floretyrosine Expanded Access Program

Study Purpose

The aim of this Expanded Access Program (EAP) is to enable the use of 18F-Floretyrosine with positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance (PET/MR) imaging to noninvasively detect tumor burden or treatment related change to assist in optimal management of patients with glioma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
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.	Expanded Access
Eligible Ages	3 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

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.	NCT06743100
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.	Telix Pharmaceuticals (Innovations) Pty Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Available
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma (Any Grade) in the Brain

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.

CU Anschutz / University of Colorado, Aurora, Colorado

Status

Available

Address

CU Anschutz / University of Colorado

Aurora, Colorado, 80045

Site Contact

Muthiah Nachiappan, MD

[email protected]

248-613-2940

Northwestern University, Chicago, Illinois

Status