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Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors

Study acronym: 3D-PEDSURG
StatusRecruiting
PhaseNot specified
Started2024-09-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
Enrollment reduced 33% 60 → 40 participants
See other at-risk trials from Assistance Publique - Hôpitaux de Paris

Amendment history

2026-09-07
critical
Study Status, Study Design, Contacts/Locations v4
Enrollment reduced: 60 → 40 participants
Primary completion pushed: 2026-08 → 2027-08
Completion pushed: 2026-09 → 2027-09
Study sites1 entry, revised
Hôpital Necker Enfants Malades. Service de Chirurgie Viscérale et Urologie pédiatrique
2026-03-19
minor
Study Status, Sponsor/Collaborators, Oversight, Eligibility v3
Collaborators2 to 3 entries
URC-CIC Paris Descartes Necker Cochin
2024-11-05
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-05→2026-08
Completion date2026-06→2026-09
Start dateestimated 2024-06→confirmed 2024-09-16
Study sitesdetails revised at 1 of 1 site
2024-06-03
minor
Study Status, Sponsor/Collaborators, Outcome Measures v1
Secondary endpointsdetails revised at 11 of 11 entries
Collaborators1 to 2 entries
Ligue contre le cancer, France
2024-05-13
minor
Original filing
This study's purpose is the comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index. It is implemented by making parents' patients, surgeons and surgical helpers answer specific questions comparing 3D images to usual 2D images of the patient's tumor.
Trial Details
NCT Number NCT06418243
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Imagine Institute, Ligue contre le cancer, France, URC-CIC Paris Descartes Necker Cochin
Conditions Pelvic Tumor, Retroperitoneal Tumor
Enrollment 40 participants
Start Date 2024-09-16
Primary Completion 2027-08 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-10