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Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme

NCT ID: NCT05908669

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-25

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GBM patients, IDH-wt

Deuterium metabolic imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Deuterium metabolic imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DMI-GBM

Identifier Type: -

Identifier Source: org_study_id