NCT06460467

Brief Summary

The aim of this study was to compare a semi-automatic segmentation method with manual reference segmentation to determine an overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor for dosimetric calculation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

June 11, 2024

Last Update Submit

February 28, 2025

Conditions

Meningioma

Keywords

dosimetrytheragnostic

Outcome Measures

Primary Outcomes (1)

  • Dice index

    Dice index between semi-automatic segmentation and reference segmentation

    1 day

Study Arms (1)

Patients treated with 177Lu-DOTATATE

Patients treated with 177Lu-DOTATATE for a meningioma at the Nancy University Hospital and for a neuroencrine tumor in the EVADOVE study NCT04467567 (who underwent scintigraphy on D1, D4 and D7 (± 1 day)

Device: scintigraphy of 177Lu-DOTATATE

Interventions

scintigraphy of 177Lu-DOTATATEDEVICE

The medical device under study is a hybrid wide-field CZT solid-state camera, the VERITON-CT ™ camera.

Patients treated with 177Lu-DOTATATE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with 177Lu-DOTATATE for a meningioma at Nancy University Hospital and for a neuroendocrine tumor in the EVADOV study who underwent scintigraphy at D1, D4 and D7 (± 1 day)

You may qualify if:

  • Patients treated with 177Lu-DOTATATE for meningioma at Nancy University Hospital
  • Patients with neuroendocrine tumors in the EVADOV study who underwent scintigraphy on D1, D4 and D7 (± 1 day)

You may not qualify if:

  • Patients who refused to have their data used retrospectively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuclear medicine Department CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

November 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 28, 2025

Last Updated

March 4, 2025

Record last verified: 2025-02

Locations

FR(1)