Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction (177Lumen)

November 27, 2023 updated by: Antoine VERGER, Central Hospital, Nancy, France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

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

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

20 patients with meningioma will be included in this study, and 10 patients of 20 will have been treated with Lutathera®.

Description

Inclusion Criteria:

  • Patients with meningioma

Exclusion Criteria:

- PET scan not available

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
20 patients with meningioma
20 meningioma patients will be included in this study, 10 of whom 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 SUVmax
Measure SUVmean (Standard Uptake Value) and SUVmax on PET exams
10 patients will have been treated with Lutathera®.
10 patients of the 20 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 SUVmax
Measure SUVmean (Standard Uptake Value) and SUVmax on PET exams

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months
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)
1 month

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Director: Anne-Sophie HUE, MSc, Chru Nancy

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)

October 1, 2022

Primary Completion (Actual)

November 6, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI

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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