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Enrolling by Invitation

NCT Number: NCT05908669

Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deuterium metabolic imaging

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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