Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction

NCT05537675 | Completed

• 1 other identifier: 2022PI
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  1 month

Study Arms (2)

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

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

Interventions

To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax OTHER

Measure SUVmean (Standard Uptake Value) and SUVmax on PET exams

10 patients will have been treated with Lutathera®.; 20 patients with meningioma

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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®.

You may qualify if:

• Patients with meningioma

You may not qualify if:

• \- PET scan not available

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nuclear medicine Department CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Anne-Sophie HUE, MSc

  CHRU Nancy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: October 1, 2022
• Primary Completion: November 6, 2022
• Study Completion: November 30, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

FR (1)