Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma

Study Purpose

The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - patients treated for menigioma at nancy hospital.
  • - patients who performed 3 scintigraphics exams during there treatment.

Exclusion Criteria:

  • - patients deprived of liberty.
- patient who refused to collect data retrospectively

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06614205
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Central Hospital, Nancy, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Meningioma of Brain
Additional Details

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.

Arms & Interventions

Arms

: 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)

Interventions

Diagnostic Test: - tumoral dosimetry by scintigraphy

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Boursier Caroline, MD

[email protected]

+33383154276

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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