MeningiomaMOLINCT06104930
Plasma Extracellular Vesicles in Meningioma Patients
A study testing Explorative biomarker study in people with Meningioma, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
While surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningioma
- What is being tested?
- Explorative biomarker study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2023to 1 Feb 2028
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- confirmed meningioma (histologically or MRI/DOTATOC-PET CT)
- macroscopic tumor in MRI (either as definitive RT, or following subtotal resection or relapse)
- indication for radiotherapy
- completed wound healing after surgical intervention)
- Alter ≥ 18 Jahre
- Karnofsky Performance Score ≥ 60%
Show all 9Show fewer
- written informed consent
- ability of subject to understand character and individual consequences of the trial
- adequate contraception for women of childbearing potential
Who cannot join
- previous or known tumor diseases < 5 years ago
- previous (cerebral) radiotherapy
- simultaneous chemo/immunotherapy
- evidence that the patient cannot adhere to the study protocol (e.g., non-compliance)
- the refusal of patients to participate in the study
- participation in another clinical study or observation period in a competing trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Adriane Lentz-Hommertgen, PhD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
Jürrgen Debus, MD PHD
About this study
Official title: Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy
While surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. Biopsies are often omitted in light of potential postoperative neurological deficits, resulting in a lack of histological grading and (molecular) risk stratification. In this prospective explorative biomarker study, extracellular vesicles in the bloodstream will be investigated in patients with macroscopic meningiomas to identify a biomarker for molecular risk stratification and disease monitoring.
Read the detailed description
In total, 60 patients with meningiomas and an indication of radiotherapy (RT) and macroscopic tumor on the planning MRI will be enrolled. Blood samples will be obtained before the start, during, and after radiotherapy, as well as during clinical follow-up every 6 months. Extracellular vesicles will be isolated from the blood samples, quantified and correlated with the clinical treatment response or progression. Further, nanopore sequencing-based DNA methylation profiles of plasma EV-DNA will be generated for methylation-based meningioma classification.
This study will explore the dynamic of plasma EVs in meningioma patients under/after radiotherapy, with the objective of identifying potential biomarkers of (early) tumor progression. DNA methylation profiling of plasma EVs in meningioma patients may enable molecular risk stratification, facilitating a molecularly-guided clinical management in meningioma patients in the future.
- Conditions
- Meningioma
- Being tested
- Explorative biomarker study
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explorative biomarker studyOther
Analysis of blood biomarker
| Study group | Role | What they receive |
|---|---|---|
| Plasma extracellular vesicles in meningioma patients following radiotherapy as liquid biopsy | Other | Explorative biomarker study Receives: Other: Explorative biomarker study |
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic of plasma EVs
Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy
Measured: until 2 years follwoing radiotherapy
Secondary outcomes (2)
progession-fee survival
number of patients without tumor progress
Measured: until 2 years follwoing radiotherapy
overall survival
number of alive patients
Measured: until 2 years follwoing radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Explorative Biomarker Study / Investigator-Initiated Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104930
- Sponsor's protocol ID
- RADONK-MOLI-2023
- Acronym
- MOLI
- Status last verified
- Mar 2026
- First submitted
- 11 Oct 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Extracellular Vesicles in Meningioma Patients Following Radiotherapy as Liquid Biopsy
- ClinicalTrials.gov ID
- NCT06104930
- Acronym / sponsor ID
- MOLI / RADONK-MOLI-2023
- Conditions
- Meningioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 27 Oct 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.
While surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. Biopsies are often omitted in light of potential postoperative neurological deficits, resulting in a lack of histological grading and (molecular) risk stratification. In this prospective explorative biomarker study, extracellular vesicles in the bloodstream will be investigated in patients with macroscopic meningiomas to identify a biomarker for molecular risk stratification and disease monitoring.
Detailed description
In total, 60 patients with meningiomas and an indication of radiotherapy (RT) and macroscopic tumor on the planning MRI will be enrolled. Blood samples will be obtained before the start, during, and after radiotherapy, as well as during clinical follow-up every 6 months. Extracellular vesicles will be isolated from the blood samples, quantified and correlated with the clinical treatment response or progression. Further, nanopore sequencing-based DNA methylation profiles of plasma EV-DNA will be generated for methylation-based meningioma classification.
This study will explore the dynamic of plasma EVs in meningioma patients under/after radiotherapy, with the objective of identifying potential biomarkers of (early) tumor progression. DNA methylation profiling of plasma EVs in meningioma patients may enable molecular risk stratification, facilitating a molecularly-guided clinical management in meningioma patients in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Explorative Biomarker Study / Investigator-Initiated Trial
| Arm | Type | Receives |
|---|---|---|
| Plasma extracellular vesicles in meningioma patients following radiotherapy as liquid biopsy | Other | Other: Explorative biomarker studyExplorative biomarker study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- confirmed meningioma (histologically or MRI/DOTATOC-PET CT)
- macroscopic tumor in MRI (either as definitive RT, or following subtotal resection or relapse)
- indication for radiotherapy
- completed wound healing after surgical intervention)
- Alter ≥ 18 Jahre
Key exclusion criteria (6 listed)
- previous or known tumor diseases < 5 years ago
- previous (cerebral) radiotherapy
- simultaneous chemo/immunotherapy
- evidence that the patient cannot adhere to the study protocol (e.g., non-compliance)
- the refusal of patients to participate in the study
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 |
|---|---|---|
| Explorative biomarker studyAnalysis of blood biomarker | Other | Plasma extracellular vesicles in meningioma patients following radiotherapy as liquid biopsy |
Primary outcome
dynamic of plasma EVs
Time frame: until 2 years follwoing radiotherapy
Change of amount of plasma EVs in meningioma patients compared to sample taken before radiotherapy
2 secondary outcomes
progession-fee survival
Time frame: until 2 years follwoing radiotherapy
overall survival
Time frame: until 2 years follwoing radiotherapy
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Adriane Lentz-Hommertgen, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explorative biomarker study in people with Meningioma, run by University Hospital Heidelberg at 1 site in Germany.
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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. 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 Germany. 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?
Contact Max Deng, MD (+496221 56 ext. 8201, maximilian.deng@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dynamic of plasma EVs (time frame: until 2 years follwoing radiotherapy). 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 10 Mar 2026.