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NCT05632562
Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
EARLY_PHASE1 trial testing O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI in High Grade Glioma in 20 participants. Currently enrolling.
1 February 2028
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 20 |
| Start date | 7 March 2024 |
| Primary completion | 1 February 2028 |
| Estimated completion | 1 February 2028 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- O-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI — full drug profile →
Conditions studied
- High Grade Glioma — all drugs for High Grade Glioma →
Sponsor
University of Alabama at Birmingham
Who can join
Adults 10 to 89, any sex, with High Grade Glioma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Amino acid metabolism in health and disease.
Ling ZN, Jiang YF, Ru JN, Lu JH, et al · · 2023 · cited 291× · PMID 37699892 · DOI 10.1038/s41392-023-01569-3 -
Recent advances of engineered oncolytic viruses-based combination therapy for liver cancer.
Zhang J, Xiao Y, Zhang J, Yang Y, et al · · 2024 · cited 8× · PMID 38167076 · DOI 10.1186/s12967-023-04817-w -
Pathways and challenges in the clinical translational of radiopharmaceuticals for pediatric investigations.
Stauff E, Karimi H, Kecskemethy HH, Shaffer TH, et al · · 2025 · PMID 41282032 · DOI 10.3389/fmed.2025.1658588
Verify or expand the search:
- PubMed search for NCT05632562
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for High Grade Glioma
Currently open trials in the same condition.
- NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
- NCT06428045 — STARLITE for Unresectable High-Grade Gliomas · Phase 1 · recruiting
- NCT06504381 — DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma · Phase 1, PHASE2 · recruiting
- NCT05843253 — Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant · Phase 2 · recruiting
- NCT05839379 — Targeted Pediatric High-Grade Glioma Therapy · recruiting
Other University of Alabama at Birmingham trials
Trials by the same sponsor.
- NCT04922229 — Comparative Effectiveness in the Management of Irreversible Pulpitis · NA · not yet recruiting
- NCT05060380 — Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis · NA · withdrawn
- NCT04768777 — Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis · NA · not yet recruiting
- NCT06320951 — VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine · Phase 2 · not yet recruiting
- NCT07564934 — Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilit · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05632562 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
- Last refreshed: 11 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05632562.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing