Refractory Meningioma177LumenNCT05537675
Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction
An observational study of Refractory Meningioma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Tumor dosimetry with somatostatin receptor-targeted peptide receptor radionuclide therapy (SSTR-targeted PRRT) by 177Lutetium-DOTATATE might contribute to improve follow-up and treatment response of refractory meningiomas. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Refractory Meningioma
- What is being tested?
- To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2022to 30 Nov 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients with meningioma will be included in this study, and 10 patients of 20 will have been treated with Lutathera®.
Who may be able to join
- Patients with meningioma
Who cannot join
- PET scan not available
Trial locations and contacts
1 site in 1 country.
France1 site
Nuclear medicine Department CHRU de NANCY
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction in Refractory Meningiomas Treated by SSTR-targeted Peptide Receptor Radionuclide Therapy
Tumor dosimetry with somatostatin receptor-targeted peptide receptor radionuclide therapy (SSTR-targeted PRRT) by 177Lutetium-DOTATATE might contribute to improve follow-up and treatment response of refractory meningiomas. This study aims to evaluate Standard Uptake Value mean (SUVmean) as a tumoral absorbed dose predictive predictive factor and propose semi-automated segmentation method to determine metabolic tumor volume with pretherapeutic 68-Gallium-DOTATOC PET.
- Conditions
- Refractory Meningioma
- Being tested
- To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmaxOther
Measure SUVmean (Standard Uptake Value) and SUVmax on PET exams
| Study group | Role | What they receive |
|---|---|---|
| 20 patients with meningioma | 20 meningioma patients will be included in this study, 10 of whom will have been treated with Lutathera®. Receives: Other: To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax | |
| 10 patients will have been treated with Lutathera®. | 10 patients of the 20 will have been treated with Lutathera®. Receives: Other: To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the SUVmean (Standard Uptake Value)as a predictive factor of the tumor absorbed dose compared to the SUVmax
Measurements of SUVmean and SUVmax at the lesion level on 68Ga-DOTATOC PET/CT Correlation between SUVmean and max measurements with tumor absorbed doses.
Measured: 2 months
To propose a semi-automated segmentation
Propose a semi-automated segmentation method for determining metabolic tumor volume with pretherapy DOTATOC labelled with gallium-68 PET. (68Ga-DOTATOC PET)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Oct 2022
- Primary completion6 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
- Investigators
- Anne-Sophie HUE, MSc, Study director, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537675
- Sponsor's protocol ID
- 2022PI
- Acronym
- 177Lumen
- Status last verified
- Nov 2023
- First submitted
- 8 Sep 2022
- Last updated
- 30 Nov 2023
- 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction in Refractory Meningiomas Treated by SSTR-targeted Peptide Receptor Radionuclide Therapy
- ClinicalTrials.gov ID
- NCT05537675
- Acronym / sponsor ID
- 177Lumen / 2022PI
- Conditions
- Refractory Meningioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Sep 2022 (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.
Tumor dosimetry with somatostatin receptor-targeted peptide receptor radionuclide therapy (SSTR-targeted PRRT) by 177Lutetium-DOTATATE might contribute to improve follow-up and treatment response of refractory meningiomas. This study aims to evaluate Standard Uptake Value mean (SUVmean) as a tumoral absorbed dose predictive predictive factor and propose semi-automated segmentation method to determine metabolic tumor volume with pretherapeutic 68-Gallium-DOTATOC PET.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 patients with meningioma | – | Other: To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax20 meningioma patients will be included in this study, 10 of whom will have been treated with Lutathera®. |
| 10 patients will have been treated with Lutathera®. | – | Other: To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax10 patients of the 20 will have been treated with Lutathera®. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with meningioma will be included in this study, and 10 patients of 20 will have been treated with Lutathera®.
Key inclusion criteria (1 listed)
- Patients with meningioma
Key exclusion criteria (1 listed)
- PET scan not available
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 |
|---|---|---|
| To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmaxMeasure SUVmean (Standard Uptake Value) and SUVmax on PET exams | Other | 10 patients will have been treated with Lutathera®., 20 patients with meningioma |
Primary outcome
To evaluate the SUVmean (Standard Uptake Value)as a predictive factor of the tumor absorbed dose compared to the SUVmax
Time frame: 2 months
Measurements of SUVmean and SUVmax at the lesion level on 68Ga-DOTATOC PET/CT Correlation between SUVmean and max measurements with tumor absorbed doses.
To propose a semi-automated segmentation
Time frame: 1 month
Propose a semi-automated segmentation method for determining metabolic tumor volume with pretherapy DOTATOC labelled with gallium-68 PET. (68Ga-DOTATOC PET)
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 30 Nov 2023.
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Active, not recruitingPhase 1
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RecruitingPhase 2
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RecruitingPhase 1/2
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
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RecruitingPhase 2
Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial
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RecruitingPhase 1/2
Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).
Solid Tumor Cancer, Medulloblastoma
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.
Anne-Sophie HUE, MSc study director
CHRU Nancy
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 Refractory 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 1 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 30 Nov 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 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?
To evaluate the SUVmean (Standard Uptake Value)as a predictive factor of the tumor absorbed dose compared to the SUVmax (time frame: 2 months). The study lists 2 primary outcomes in all. 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 30 Nov 2023.