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NCT05632562 · ClinicalTrials.gov registry record · Early Phase 1
Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
A Early Phase 1 study of High Grade Glioma, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT05632562: Recruiting Early Phase 1 study of High Grade Glioma, sponsored by University of Alabama at Birmingham.
NCT05632562 is a Early Phase 1 study of High Grade Glioma that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 20 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05632562, a Early Phase 1 study of High Grade Glioma, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The frequency of the detection of viable tumor by FET and/or FMISO based on prespecified standardized uptake values (SUVs) and lesion to normal brain ratios will be measured. We expect to detect viable glioma in at least 25% of patients at this time point.
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 |
What NCT05632562 shows while recruiting
NCT05632562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (69% lower).
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.
NCT05632562 reports a single indexed study location in Alabama.
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.
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).
Who is sponsoring clinical trial NCT05632562?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05632562's enrollment target sits among peer trials
20 31st of 42 higher than 12 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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