Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme

Glioblastoma Multiforme Clinical Trial

Official title:

Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05908669
• Other study ID #: DMI-GBM
• Status: Enrolling by invitation
• Start date: August 25, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subjects who are receiving any other investigational agents.
• Previous or current treatment by radiation or chemotherapy.
• History of alcohol abuse or illicit drug use.
• 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
• Contraindications to gadolinium contrast eGFR = 30 mL/min/1.73m2 Previous adverse reactions to gadolinium
• Not able or willing to receive radiotherapy
• Predicted remaining survival <3 months
• Insulin-treated diabetes

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Diagnostic Test:
• Deuterium metabolic imaging
MRI after oral administration of 75g of [6,6'-2H2]glucose.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deuterium Metabolic Imaging	2H-glucose uptake and conversion to lactate and glx over 120 minutes in normal brain and tumor tissue. Before and after radiochemotherapy to measure the changes with therapy.	Imaging repeated twice with ~10 weeks between them.
Secondary	Perfusion MRI	Dynamic contrast enhancement MRI using a gadolinium-based contrast agent.	Imaging repeated twice with ~10 weeks between them.
Secondary	Microvascular diffusion MRI	Diffusion-weighted MRI.	Imaging repeated twice with ~10 weeks between them.
Secondary	Amide proton transfer weighted MRI	APT-CEST MRI.	Imaging repeated twice with ~10 weeks between them.
Secondary	Progression-free survival	Time until progression or death.	Until an event (average 6 months) or closure of the protocol after 4 years.
Secondary	Overall survival	Time until death.	Until an event (average 15 months) or closure of the protocol after 4 years.