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

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.

Study Overview

• Status: Terminated
• Conditions: Upper Digestive Tract Cancer
• Intervention / Treatment: Procedure: Therapeutic assessment -Radio-surgical guidance.

Detailed Description

• Investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps
• Investigate the accuracy of inserting implants in the anteroposterior way, in the vertical way and in angulation for all the involved patients (meaning on irradiated native mandible or on microanastomosed fibula flaps)
• Investigate the delay of mucous healing
• Estimate the prosthetic function
• Evaluate the osteonecrosis rate after radiation with traumatic etiology due to implantation
• Estimate the implant rate due to minimally invasive flaps
• Estimate the implant rate due to pure trans mucosa way
• Estimate the post surgical therapeutic success after 1 year

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63 000
    • CHU Hôtel-Dieu Service d'Odontologie
  • Lyon, France, 69007
    • Hospices Civils de Lyon Service de Consultations et Traitements Dentaires
  • Pierre Benite, France, 69495
    • Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale
  • Cedex 08
    • Lyon, Cedex 08, France, 69373
      • Centre Léon Bérard Service de Chirurgie-Stomatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age over 18
• Performance status over 70
• Histological evidence of upper digestive tract cancer
• History of cranial / facial radiotherapy or brachytherapy and/or microvascular fibula transfer.
• Bone volume sufficient to support an implant.
• Mandatory affiliation with a social security system
• Written, voluntary, informed consent

Exclusion Criteria:

• Patient with evolutive malignant disease
• Contraindication to general anesthesia
• Concurrent disease contra-indicating implant surgery (risk of infectious endocarditis, uncontrolled diabetes, HIV, evolutive neoplasia…)
• Patient enrolled in another clinical trial including chemotherapy
• Pregnant or lactating woman
• Anticipation of an impossible follow-up
• Patient deprived of freedom

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Accuracy of implants insertion, radio-surgical guidance.	8 months after inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Accuracy of inserting implants	16 months after inclusion
Delay of mucous healing	16 months after inclusion
Estimation of the prosthetic function	16 months after inclusion
Osteonecrosis rate after radiation with traumatic etiology due to implantation	16 months after inclusion
Implant rate	16 months after inclusion
Post surgical therapeutic success after 1 year	after 1 year

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: French Academic Institution, Financial support: PHRC 2007
• Investigators: Principal Investigator: Anne-Gaëlle BODARD, MD, Centre Léon Bérard

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: June 2, 2009
• First Submitted That Met QC Criteria: June 19, 2009
• First Posted (Estimate): June 22, 2009

Study Record Updates

• Last Update Posted (Estimate): June 22, 2011
• Last Update Submitted That Met QC Criteria: June 21, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: upper digestive tract cancer; implants; implants insertion; radio-surgical guidance; accuracy of implants insertion; cranial/facial radiotherapy or brachytherapy and/or microvascular fibula transfer.; Bone volume sufficient to support an implant
• Other Study ID Numbers: ET2006-032; CPP 07/033 [UBET83]