Glioma (Any Grade) in the BrainNCT06743100
18F-Floretyrosine Expanded Access Program
A study testing 18F-Floretyrosine in people with Glioma (Any Grade) in the Brain, run by Telix Pharmaceuticals (Innovations) Pty Limited at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Glioma (Any Grade) in the Brain
- What is being tested?
- 18F-Floretyrosine
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
- Male or female ≥ 3 years of age at time of consent/assent
- Diagnosis or clinical suspicion of glioma (any grade) in the brain
- At the time of screening have undergone therapy for glioma
- 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
- 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.
Who cannot join
- 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).
- Women who are pregnant or breastfeeding.
- 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).
- 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.
- 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.
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date planned administration of 18F-Floretyrosine.
- Known hypersensitivity to floretyrosine or tyrosine derivatives.
- Unable to tolerate the program procedures.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
CU Anschutz / University of Colorado
Aurora, Colorado, 80045
Johns Hopkins Baltimore
Baltimore, Maryland, 21205
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
Kettering Health Main Campus
Kettering, Ohio, 45429
University Wisconsin Madison
Madison, Wisconsin, 53705-2275
MSKCC (Memorial Sloan Kettering Cancer Center)
New York, New York, 10065
UC Irvine
Orange, California, 92868
University Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Expanded Access Program for the Non-invasive Characterization of Glioma or Treatment Related Change Utilizing Fluorine (F-18) Floretyrosine (18F-FET, TLX101-CDx)
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.
- Conditions
- Glioma (Any Grade) in the Brain
- Being tested
- 18F-Floretyrosine
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FloretyrosineDiagnostic test
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma (Any Grade) in the BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743100
- Sponsor's protocol ID
- 18F-TLX101-CDX-002
- Status last verified
- May 2026
- First submitted
- 16 Dec 2024
- Last updated
- 29 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program for the Non-invasive Characterization of Glioma or Treatment Related Change Utilizing Fluorine (F-18) Floretyrosine (18F-FET, TLX101-CDx)
- ClinicalTrials.gov ID
- NCT06743100
- Acronym / sponsor ID
- 18F-TLX101-CDX-002
- Conditions
- Glioma (Any Grade) in the Brain
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Male or female ≥ 3 years of age at time of consent/assent
- Diagnosis or clinical suspicion of glioma (any grade) in the brain
- At the time of screening have undergone therapy for glioma
- 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
Key exclusion criteria (8 listed)
- 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).
- Women who are pregnant or breastfeeding.
- 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).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FloretyrosineSingle 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. | Diagnostic test | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-Floretyrosine in people with Glioma (Any Grade) in the Brain, run by Telix Pharmaceuticals (Innovations) Pty Limited at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.