NCT05908669Enrolling by invitation
Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme
Source: ClinicalTrials.gov · Last updated 7 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a feasibility single arm study designed for obtaining early data for optimization and evaluation of the clinical potential for a new MR technique using deuterated glucose. The purpose of the study is to investigate whether this technique is useful in metabolic imaging of glioblastoma multiforme (GBM) and whether radiochemotherapy (RCT) induced changes in the brain metabolism can be detected and might be predictive for treatment response. The study will include 10 patients with histologically verified GBM scheduled for standard RCT. Patients will have MRI scan performed before and within 8 weeks after starting RCT. The scans will include imaging after oral intake of deuterated glucose, so called deuterium metabolic imaging (DMI). Based on this study, the most optimal scanning technique, output variables of highest discriminative power with respect to RCT, and potential predictive markers for response will be selected for further clinical investigation.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 15 May 2023
- Start date
- 25 Aug 2023
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- University of Aarhus
- Diseases
- Glioblastoma
- NCT number
- NCT05908669
What you commit to
- Study type: Observational
- Planned participants: 10
- From 25 Aug 2023 to the primary completion date, 1 Aug 2024
- 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
- Subjects who are receiving any other investigational agents.
- Previous or current treatment by radiation or chemotherapy.
- Contraindications to MRI Pacemaker, neurostimulator or cochlea implant Metal foreign bodies such as fragments and irremovable piercings Unsafe medical implants Intracranial clips or coils Claustrophobia Largest circumference including arms \> 160 cm
- Not able or willing to receive radiotherapy
Other illness
- History of alcohol abuse or illicit drug use.
- Insulin-treated diabetes
Lab values
- Contraindications to gadolinium contrast eGFR ≤ 30 mL/min/1.73m2 Previous adverse reactions to gadolinium
Other
- Predicted remaining survival \<3 months
Who the study is looking for
- Patients with newly diagnosed GBM IDHwt
- Scheduled for long-course radiotherapy
- At least 18 years of age
- WHO performance status 0-1
- Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device.
- Danish speaking
- Able and willing to comply after informed consent
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Aarhus University Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.