Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Patients Diagnosed With a Gl… (NCT07735819) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Patients Diagnosed With a Glioma
United States61 participantsStarted 2026-09
Plain-language summary
The goal of this clinical trial is to evaluate Positron emission tomography/computed tomography (PET/CT) imaging with the radiotracer 1-(2-\[18F\]fluoroethyl)-l-tryptophan (\[18F\]FETrp) in patients diagnosed with a glioma. This study has 3 aims:
* to assess if the \[18F\]FETrp PET/CT can outperform Magnetic Resonance Imaging (MRI) by providing a better treatment target volume in newly diagnosed Stage 4 glioma patients
* better differentiate tumor progression from radiation induced MRI changes in post treatment stage 4 gliomas
* by giving a drug that can inhibit a pathway to allow objective assessment of treatment effects in low grade gliomas
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
FOR ARMS 1-3
Inclusion Criteria:
* Age =18 years.
* Patient is able to lie in the PET/CT scanner for at least 60 minutes while undergoing scanning.
* Patient is willing and able to review, understand, and provide written consent for the study procedures and indicates that they are aware of the investigational nature of this study.
Exclusion Criteria:
* Patients who are pregnant or lactating are excluded. Premenopausal women (defined per institutional guidelines) must have a negative pregnancy test (urine or serum) within 7 days of the PET scan.
* Severe increased intracranial pressure, status epilepticus, or other severe or progressing clinical symptoms requiring urgent intervention in the opinion of the treating
* Karnofsky performance score \<60, as determined by one of the clinician co- investigators.
ADDITIONAL CRITERIA FOR ARM 1:
Inclusion Criteria:
* Histopathology/cytopathological diagnosis of a glioblastoma without a history of radiation.
* The tumor is deemed amenable for radiation treatment (pre-radiation planning MRI can be done before or after the PET scan).
ADDITIONAL CRITERIA FOR ARM 2:
Inclusion Criteria:
* Previous histopathology/cytopathological diagnosis of glioblastoma.
* History of glioma radiation.
* Presence of a new or progressing enhancing brain lesion on follow-up clinical MRI suspicious for post-radiation glioma progression or late radiation-induced MRI changes (i.e., radiation injury), at least 7 mm in bidirectional diameter.
* The most re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference Between Dice Similarity Coefficients (DSC) of Position Emission Tomography (PET) High K Tumor Volume and DSC of MRI-based Tumor Volume (d-PETk-MRI) in Arm 1
Timeframe: From the time of the pre-radiotherapy scans (Baseline) up to tumor progression or study completion, assessed at a maximum follow-up of 2 years.
2
Sensitivity of [18F]FETrp PET Kinetic Influx Rate (PETk) with a predefined L/C ratio threshold of 1.60 in differentiating Tumor Progression from Radiation Injury in Arm 2
Timeframe: From the date of the [18F]FETrp PET/CT scan up to the date of confirmed ground truth designation via histopathology or serial MRI follow-up, assessed over a maximum period of 1 year per participant.
3
Change in [18F]FETrp Kinetic Influx Rate (K) Values Following One Month of Standard of Care Plus Indoleamine 2,3-dioxygenase (IDO) Inhibitor Treatment (d-PETK) in Arm 3
Timeframe: From Baseline (within 2 weeks prior to treatment initiation) to 1-month post-treatment (30 days ± 5 days, up to 44 days).