Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme

NCT05908669 | Enrolling By Invitation

• 1 other identifier: DMI-GBM
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Perfusion MRI

  Imaging repeated twice with ~10 weeks between them.

• Microvascular diffusion MRI

  Imaging repeated twice with ~10 weeks between them.

• Amide proton transfer weighted MRI

  Imaging repeated twice with ~10 weeks between them.

• Progression-free survival

  Until an event (average 6 months) or closure of the protocol after 4 years.

• Overall survival

  Until an event (average 15 months) or closure of the protocol after 4 years.

Study Arms (1)

GBM patients, IDH-wt

Diagnostic Test: Deuterium metabolic imaging

Interventions

Deuterium metabolic imaging DIAGNOSTIC_TEST

MRI after oral administration of 75g of \[6,6'-2H2\]glucose.

GBM patients, IDH-wt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with newly diagnosed GBM IDHwt
• Scheduled for long-course radiotherapy
• At least 18 years of age
• WHO performance status 0-1
• Danish speaking
• Able and willing to comply after informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 18, 2023
• Study Start: August 25, 2023
• Primary Completion: August 1, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-05

Locations

DK (1)