Glioblastoma MultiformeNCT05908669
Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme
An observational study of Glioblastoma Multiforme, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Deuterium metabolic imaging
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Aug 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Deuterium metabolic imaging
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterium metabolic imagingDiagnostic test
MRI after oral administration of 75g of [6,6'-2H2]glucose.
| Study group | Role | What they receive |
|---|---|---|
| GBM patients, IDH-wt | Not described Receives: Diagnostic Test: Deuterium metabolic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Imaging repeated twice with ~10 weeks between them.
Secondary outcomes (5)
Perfusion MRI
Dynamic contrast enhancement MRI using a gadolinium-based contrast agent.
Measured: Imaging repeated twice with ~10 weeks between them.
Microvascular diffusion MRI
Diffusion-weighted MRI.
Measured: Imaging repeated twice with ~10 weeks between them.
Amide proton transfer weighted MRI
APT-CEST MRI.
Measured: Imaging repeated twice with ~10 weeks between them.
Progression-free survival
Time until progression or death.
Measured: Until an event (average 6 months) or closure of the protocol after 4 years.
Overall survival
Time until death.
Measured: Until an event (average 15 months) or closure of the protocol after 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908669
- Sponsor's protocol ID
- DMI-GBM
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared in anonymized form if the local juridical office accepts that full anonymization can be achieved.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT05908669
- Acronym / sponsor ID
- DMI-GBM
- Conditions
- Glioblastoma Multiforme
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBM patients, IDH-wt | – | Diagnostic Test: Deuterium metabolic imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deuterium metabolic imagingMRI after oral administration of 75g of [6,6'-2H2]glucose. | Diagnostic test | GBM patients, IDH-wt |
Primary outcome
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.
5 secondary outcomes
Perfusion MRI
Time frame: Imaging repeated twice with ~10 weeks between them.
Microvascular diffusion MRI
Time frame: Imaging repeated twice with ~10 weeks between them.
Amide proton transfer weighted MRI
Time frame: Imaging repeated twice with ~10 weeks between them.
Progression-free survival
Time frame: Until an event (average 6 months) or closure of the protocol after 4 years.
Overall survival
Time frame: Until an event (average 15 months) or closure of the protocol after 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided. Data will be shared in anonymized form if the local juridical office accepts that full anonymization can be achieved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma Multiforme, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deuterium Metabolic Imaging (time frame: Imaging repeated twice with ~10 weeks between them.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.