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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 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.

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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.

Conditions Studied

High Grade Glioma

Interventions

  • DRUG O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI

Study Locations (2)

Alabama

  • UAB - Birmingham
  • UAB - Birmingham

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-03-07
Est. Completion 2028-02-01
Phase Early Phase 1

Sponsor

University of Alabama at Birmingham

1,160 total trials

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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, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (69% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.