Meningioma of BrainDATUMNCT06614205
Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma
An observational study of Meningioma of Brain, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma of Brain
- What is being tested?
- tumoral dosimetry by scintigraphy
- How many people
- 11 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Nov 2024to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: patients treated with 177Lu-DOTATATE for meningioma at Nancy University Hospital
Who may be able to join
- patients treated for menigioma at nancy hospital
- patients who performed 3 scintigraphics exams during there treatment
Who cannot join
- patients deprived of liberty
- patient who refused to collect data retrospectively
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de NANCY
Vandœuvre-lès-Nancy, 54511
Nuclear medicine Department CHRU de NANCY
Vandœuvre-lès-Nancy, 54511
About this study
The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas.
Read the detailed description
Dosimetry is essential for Peptide Receptor Radionuclide Therapy (PRRT) of meningiomas, to predict efficacy and dose-effect relationships at the individual level, and to move towards personalized medicine. Due to the increasing therapeutic applications of Lutathera, the European Association of Nuclear Medicine (EANM) recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues. Nevertheless, despite these recommendations, the evaluation of meningioma tumor dosimetry in Peptide Receptor Radionuclide Therapy studies is not systematic, which has not enabled us to clearly determine the dose delivered to the meningioma lesion in these treatments and the possible dose-response relationship in this type of treatment.
- Conditions
- Meningioma of Brain
- Being tested
- tumoral dosimetry by scintigraphy
- Keywords
- meningioma, theragnostic, dosimetry
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumoral dosimetry by scintigraphyDiagnostic test
The tumoral dosimetry has been done on patient after treatment by 177Lu-DOTATATE Theses patients performed a scintigraphy exam at D1, D4 and D7 after the treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with 177Lu-DOTATATE for meningioma | Patients treated with 177Lu-DOTATATE for meningioma at the Nancy's hospital who met the treatment criteria of the Compassionate Prescribing Framework and received a scintigraphy at D1, D4 and D7 (± 1 day) Receives: Diagnostic Test: tumoral dosimetry by scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy for progression free survival
Accuracy of tumor dosimetry to predict 6-month progression-free survival.
Measured: Day 1
Secondary outcomes (1)
Diagnostic accuracy for overal survival
Accuracy of tumoral dosimetry in predicting 6-month overall survival
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Nov 2024
- Primary completion1 Jan 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningioma of BrainStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOURSIER Caroline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614205
- Sponsor's protocol ID
- 2024PI102
- Acronym
- DATUM
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boursier C, Zaragori T, Garabedian N, Blonski M, Obara T, Taillandier L, Imbert L, Verger A. [177Lu]Lu-DOTATATE for refractory meningiomas: factors associated with the therapeutic response and initial tumor dosimetric data. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):2047-2053. doi: 10.1007/s00259-025-07555-x. Epub 2025 Sep 22.
PubMed 40982021
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma
- ClinicalTrials.gov ID
- NCT06614205
- Acronym / sponsor ID
- DATUM / 2024PI102
- Conditions
- Meningioma of Brain
- Keywords
- meningioma, theragnostic, dosimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 26 Sep 2024 (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.
The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas.
Detailed description
Dosimetry is essential for Peptide Receptor Radionuclide Therapy (PRRT) of meningiomas, to predict efficacy and dose-effect relationships at the individual level, and to move towards personalized medicine. Due to the increasing therapeutic applications of Lutathera, the European Association of Nuclear Medicine (EANM) recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues. Nevertheless, despite these recommendations, the evaluation of meningioma tumor dosimetry in Peptide Receptor Radionuclide Therapy studies is not systematic, which has not enabled us to clearly determine the dose delivered to the meningioma lesion in these treatments and the possible dose-response relationship in this type of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with 177Lu-DOTATATE for meningioma | – | Diagnostic Test: tumoral dosimetry by scintigraphyPatients treated with 177Lu-DOTATATE for meningioma at the Nancy's hospital who met the treatment criteria of the Compassionate Prescribing Framework and received a scintigraphy at D1, D4 and D7 (± 1 day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients treated with 177Lu-DOTATATE for meningioma at Nancy University Hospital
Key inclusion criteria (2 listed)
- patients treated for menigioma at nancy hospital
- patients who performed 3 scintigraphics exams during there treatment
Key exclusion criteria (2 listed)
- patients deprived of liberty
- patient who refused to collect data retrospectively
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 |
|---|---|---|
| tumoral dosimetry by scintigraphyThe tumoral dosimetry has been done on patient after treatment by 177Lu-DOTATATE Theses patients performed a scintigraphy exam at D1, D4 and D7 after the treatment | Diagnostic test | Patients treated with 177Lu-DOTATATE for meningioma |
Primary outcome
Diagnostic accuracy for progression free survival
Time frame: Day 1
Accuracy of tumor dosimetry to predict 6-month progression-free survival.
1 secondary outcome
Diagnostic accuracy for overal survival
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 40982021Boursier C, Zaragori T, Garabedian N, Blonski M, Obara T, Taillandier L, Imbert L, Verger A. [177Lu]Lu-DOTATATE for refractory meningiomas: factors associated with the therapeutic response and initial tumor dosimetric data. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):2047-2053. doi: 10.1007/s00259-025-07555-x. Epub 2025 Sep 22.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma of Brain, run by Central Hospital, Nancy, France at 2 sites in France.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy for progression free survival (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614205, which also lists 1 linked publication.
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 25 Jun 2026.