MeningiomaSSTRNCT06460467
Semi-automatic Segmentation Method for Determining 177Lu-DOTATATE Tumor Dosimetry
An observational study of Meningioma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The aim of this study was to compare a semi-automatic segmentation method with manual reference segmentation to determine an overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor for dosimetric calculation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- scintigraphy of 177Lu-DOTATATE
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 28 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 a meningioma at Nancy University Hospital and for a neuroendocrine tumor in the EVADOV study who underwent scintigraphy at D1, D4 and D7 (± 1 day)
Who may be able to join
- Patients treated with 177Lu-DOTATATE for meningioma at Nancy University Hospital
- Patients with neuroendocrine tumors in the EVADOV study who underwent scintigraphy on D1, D4 and D7 (± 1 day)
Who cannot join
- Patients who refused to have their data used retrospectively
Trial locations and contacts
1 site in 1 country.
France1 site
Nuclear medicine Department CHRU de NANCY
Vandœuvre-lès-Nancy, 54511
About this study
The aim of this study was to compare a semi-automatic segmentation method with manual reference segmentation to determine an overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor for dosimetric calculation.
Read the detailed description
The new wide-field solid-state cameras enable "quantitative" single-photon emission tomoscintigraphy (SPECT) acquisitions, particularly during internal vectorized radiotherapy treatments. These innovative treatments are mainly used in cancer therapy. They involve the injection of a radiopharmaceutical consisting of a vector specifically targeting the tumor cell - in this case, somatostatin analogues targeting somatostatin receptors - and a radioactive isotope emitting β- or α-radiation to "kill" the tumor cell, and γ-radiation for SPECT imaging - in this case 177Lu. These radiopharmaceuticals are currently prescribed at fixed doses for all patients. With the aim of personalized medicine, tumor dosimetry is essential for predicting efficacy and dose-response relationships at the individual level of this type of treatment. In view of the increasing therapeutic applications of these 177Lu therapies, the European Association of Nuclear Medicine (EANM) has recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues (Lutathéra®, 177Lu-DOTATATE), among others.
Nevertheless, these recommendations are precise as regards dosimetry to organs at risk, but remain unclear as regards tumor dosimetry. Tumor dosimetry is therefore difficult to implement on a routine clinical basis.
The efficacy of 177Lu-DOTATATE treatment has been demonstrated for neuroendocrine tumors in the NETTER-1 phase 3 study, and interesting results have been reported for the treatment of refractory meningiomas.
Furthermore, a recent study showed that in patients with gastrointestinal neuroendocrine tumors treated with 177Lu-DOTATATE, tumor dosimetry could predict patient survival.
In order to optimize a dosimetric approach in clinical routine, several steps are necessary: i) define a standardized manual or semi-automated segmentation method for determining the volumes of interest (tumor volume and/or organs at risk), ii) precisely quantify tumor or organs at risk volume activities over time, and iii) determine the doses absorbed by the tumor and/or organs at risk.
An initial study was conducted in the department of nuclear medicine,to define a semi-automatic segmentation method for meningiomas treated with 177Lu-DOTATATE on pre-therapeutic 68Ga-DOTATOC positons emission tomography (PET), with the aim of predicting tumor dosimetry from pretherapeutic imaging. For this study, tumor segmentation will be performed directly on SPECT imaging carried out post-treatment on a 360° wide-field CZT camera to determine tumor dosimetry.
The aim of this study is to compare a semi-automatic segmentation method with manual reference segmentation to determine overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor, with a view to dosimetric calculation.
- Conditions
- Meningioma
- Being tested
- scintigraphy of 177Lu-DOTATATE
- Keywords
- dosimetry, theragnostic
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scintigraphy of 177Lu-DOTATATEDevice
The medical device under study is a hybrid wide-field CZT solid-state camera, the VERITON-CT ™ camera.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with 177Lu-DOTATATE | Patients treated with 177Lu-DOTATATE for a meningioma at the Nancy University Hospital and for a neuroencrine tumor in the EVADOVE study NCT04467567 (who underwent scintigraphy on D1, D4 and D7 (± 1 day) Receives: Device: scintigraphy of 177Lu-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dice index
Dice index between semi-automatic segmentation and reference segmentation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Nov 2024
- Primary completion1 Jan 2025
- Study completion28 Feb 2025
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 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
- 25 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
- NCT06460467
- Sponsor's protocol ID
- 2024PI103
- Acronym
- SSTR
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-automatic Segmentation Method for Determining 177Lu-DOTATATE Tumor Dosimetry
- ClinicalTrials.gov ID
- NCT06460467
- Acronym / sponsor ID
- SSTR / 2024PI103
- Conditions
- Meningioma
- Keywords
- dosimetry, theragnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 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
- 28 Feb 2025 (actual)
- First posted
- 14 Jun 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 aim of this study was to compare a semi-automatic segmentation method with manual reference segmentation to determine an overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor for dosimetric calculation.
Detailed description
The new wide-field solid-state cameras enable "quantitative" single-photon emission tomoscintigraphy (SPECT) acquisitions, particularly during internal vectorized radiotherapy treatments. These innovative treatments are mainly used in cancer therapy. They involve the injection of a radiopharmaceutical consisting of a vector specifically targeting the tumor cell - in this case, somatostatin analogues targeting somatostatin receptors - and a radioactive isotope emitting β- or α-radiation to "kill" the tumor cell, and γ-radiation for SPECT imaging - in this case 177Lu. These radiopharmaceuticals are currently prescribed at fixed doses for all patients. With the aim of personalized medicine, tumor dosimetry is essential for predicting efficacy and dose-response relationships at the individual level of this type of treatment. In view of the increasing therapeutic applications of these 177Lu therapies, the European Association of Nuclear Medicine (EANM) has recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues (Lutathéra®, 177Lu-DOTATATE), among others.
Nevertheless, these recommendations are precise as regards dosimetry to organs at risk, but remain unclear as regards tumor dosimetry. Tumor dosimetry is therefore difficult to implement on a routine clinical basis.
The efficacy of 177Lu-DOTATATE treatment has been demonstrated for neuroendocrine tumors in the NETTER-1 phase 3 study, and interesting results have been reported for the treatment of refractory meningiomas.
Furthermore, a recent study showed that in patients with gastrointestinal neuroendocrine tumors treated with 177Lu-DOTATATE, tumor dosimetry could predict patient survival.
In order to optimize a dosimetric approach in clinical routine, several steps are necessary: i) define a standardized manual or semi-automated segmentation method for determining the volumes of interest (tumor volume and/or organs at risk), ii) precisely quantify tumor or organs at risk volume activities over time, and iii) determine the doses absorbed by the tumor and/or organs at risk.
An initial study was conducted in the department of nuclear medicine,to define a semi-automatic segmentation method for meningiomas treated with 177Lu-DOTATATE on pre-therapeutic 68Ga-DOTATOC positons emission tomography (PET), with the aim of predicting tumor dosimetry from pretherapeutic imaging. For this study, tumor segmentation will be performed directly on SPECT imaging carried out post-treatment on a 360° wide-field CZT camera to determine tumor dosimetry.
The aim of this study is to compare a semi-automatic segmentation method with manual reference segmentation to determine overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor, with a view to dosimetric calculation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with 177Lu-DOTATATE | – | Device: scintigraphy of 177Lu-DOTATATEPatients treated with 177Lu-DOTATATE for a meningioma at the Nancy University Hospital and for a neuroencrine tumor in the EVADOVE study NCT04467567 (who underwent scintigraphy on 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 a meningioma at Nancy University Hospital and for a neuroendocrine tumor in the EVADOV study who underwent scintigraphy at D1, D4 and D7 (± 1 day)
Key inclusion criteria (2 listed)
- Patients treated with 177Lu-DOTATATE for meningioma at Nancy University Hospital
- Patients with neuroendocrine tumors in the EVADOV study who underwent scintigraphy on D1, D4 and D7 (± 1 day)
Key exclusion criteria (1 listed)
- Patients who refused to have their data used 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 |
|---|---|---|
| scintigraphy of 177Lu-DOTATATEThe medical device under study is a hybrid wide-field CZT solid-state camera, the VERITON-CT ™ camera. | Device | Patients treated with 177Lu-DOTATATE |
Primary outcome
Dice index
Time frame: 1 day
Dice index between semi-automatic segmentation and reference segmentation
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 4 Mar 2025.
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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.
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 Meningioma, run by Central Hospital, Nancy, France at 1 site 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 1 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 4 Mar 2025. 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 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?
Dice index (time frame: 1 day). 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 4 Mar 2025.