NCT05632562RecruitingEarly phase 1
Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 9 Nov 2022
- Start date
- Mar 2024
- Primary completion date
- Feb 2028
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Childhood cancers
- NCT number
- NCT05632562
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From Mar 2024 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of bevacizumab or an investigational therapeutic drug for any indication within 3 months prior to the imaging study.
Other illness
- Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team
Lab values
- Significant renal dysfunction (estimated GFR \< 30 mL/min)
Other
- Recurrent glioma
- Pregnancy or breast feeding
- Inability to complete PET/MRI scans.
- Time interval greater than 12 weeks between the completion of RT and performance of FET and FMISO PET/MRI studies.
Who the study is looking for
- Histologically confirmed newly diagnosed grade III or grade IV glioma treated with standard of care external beam radiation therapy (RT). For diffuse midline glioma involving the pons (diffuse intrinsic pontine glioma), histological confirmation is not required. Surgical resection of the glioma prior to RT and/or concurrent temozolomide (TMZ) with RT are allowed but not required.
- 10 years of age or older at the time of enrollment
- Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with an anxiolytic such as alprazolam used routinely for SOC MRI is allowed.
- Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum beta-hCG test within 48 hours prior to the administration of FET or FMISO.
- ECOG performance score of 2 or better in adults. For patients less than 16 years of age, Modified Lansky score ≥ 60.
- Life expectancy greater than 12 weeks.
Age in the registry: 10 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAB Coordinator of this site? Confirm its status | Birmingham | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.