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Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
NCT05632562 · View on ClinicalTrials.gov ↗
Study Summary
This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-(\[2-\[F-18\]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-\[F-18\]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies.
Conditions Studied
Interventions
- DRUG O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI
Study Locations (2)
Alabama
- UAB — Birmingham
- UAB — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2028-02-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05632562
The ClinicalTrials.gov registry entry for NCT05632562 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with High Grade Glioma appearing as the primary indexed condition, and to 1 intervention — of which O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05632562 reports 2 study locations spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05632562 about?
NCT05632562 is a clinical study titled "Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma". This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous posit...
What is the current status of trial NCT05632562?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2024-03-07. Estimated completion is 2028-02-01.
What conditions does trial NCT05632562 study?
This clinical trial studies the following conditions: High Grade Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05632562?
The interventions under investigation include: O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05632562?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05632562 being conducted?
This trial has 2 study locations across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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