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

February 28, 2025 updated by: BOURSIER Caroline, Central Hospital, Nancy, France
The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre les Nancy cedex, France, 54511
        • Nuclear medicine Department CHRU de NANCY
      • Vandoeuvre les Nancy cedex, France, 54511
        • CHRU de NANCY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients treated with 177Lu-DOTATATE for meningioma at Nancy University Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy for progression free survival
Time Frame: Day 1
Accuracy of tumor dosimetry to predict 6-month progression-free survival.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy for overal survival
Time Frame: Day 1
Accuracy of tumoral dosimetry in predicting 6-month overall survival
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

February 25, 2025

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PI102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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