Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme

• ClinicalTrials.gov Identifier: NCT05908669
• Recruitment Status: Enrolling by invitation
• First Posted: June 18, 2023
• Last Update Posted: December 7, 2023
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Glioblastoma Multiforme	Diagnostic Test: Deuterium metabolic imaging

Study Design

• Study Type: Observational
• Estimated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme
• Actual Study Start Date: August 25, 2023
• Estimated Primary Completion Date: August 1, 2024
• Estimated Study Completion Date: December 31, 2026

Groups and Cohorts

Group/Cohort	Intervention/treatment
GBM patients, IDH-wt	Diagnostic Test: Deuterium metabolic imaging; MRI after oral administration of 75g of [6,6'-2H2]glucose.

Outcome Measures

Primary Outcome Measures :

1. Deuterium Metabolic Imaging [ Time Frame: Imaging repeated twice with ~10 weeks between them. ]
   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.

Secondary Outcome Measures :

1. Perfusion MRI [ Time Frame: Imaging repeated twice with ~10 weeks between them. ]
   Dynamic contrast enhancement MRI using a gadolinium-based contrast agent.
2. Microvascular diffusion MRI [ Time Frame: Imaging repeated twice with ~10 weeks between them. ]
   Diffusion-weighted MRI.
3. Amide proton transfer weighted MRI [ Time Frame: Imaging repeated twice with ~10 weeks between them. ]
   APT-CEST MRI.
4. Progression-free survival [ Time Frame: Until an event (average 6 months) or closure of the protocol after 4 years. ]
   Time until progression or death.
5. Overall survival [ Time Frame: Until an event (average 15 months) or closure of the protocol after 4 years. ]
   Time until death.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed GBM, idh-wt (performance 0-1) are enrolled before initiating radiochemotherapy. They are not allowed to have contraindications to MRI with contrast or diabetes.

Criteria

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

Contacts and Locations

Locations

Denmark

Aarhus University

Aarhus, Denmark, 8200

Sponsors and Collaborators

University of Aarhus

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT05908669
• Other Study ID Numbers: DMI-GBM
• First Posted: June 18, 2023
• Last Update Posted: December 7, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Data will be shared in anonymized form if the local juridical office accepts that full anonymization can be achieved.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glioblastoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue