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Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

NCT00925509 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2011-06-22

No results posted yet for this study

Summary

Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

Conditions

  • Upper Digestive Tract Cancer

Interventions

PROCEDURE

Therapeutic assessment -Radio-surgical guidance.

The first steps of the procedure include the production of a radiosurgical guide and the preparation of a mask in order to allow precise, non invasive repositioning of the guide. Secondarily, the patient undergoes a CT-scan with the mask on and the radiosurgical guide in place. This provisional scan is used for preimplantation evaluation and drilling of the guide hole. Under general anaesthesia, the mask is placed on the patient and the guide is fixed to the mask. A hole is drilled with a burr in the mandible through the hole in the guide. Implants are placed and the guide and mask are removed. A second, post-implantation CT-scan is planned 3 months after implantation. Comparison of pre- and post-implantation CT-scans allows to evaluate the precision of the placement.

Sponsors & Collaborators

  • French Academic Institution, Financial support: PHRC 2007

    collaborator UNKNOWN

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Anne-Gaëlle BODARD, MD · Centre Leon Berard

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925509 on ClinicalTrials.gov