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

This study has been terminated.
(Insufficient recruitment, too much selective inclusion criteria, feasibility problems)
Sponsor:
Collaborator:
French Academic Institution, Financial support: PHRC 2007
Information provided by:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00925509
First received: June 2, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Upper Digestive Tract Cancer
Procedure: Therapeutic assessment -Radio-surgical guidance.

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Accuracy of implants insertion, radio-surgical guidance. [ Time Frame: 8 months after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Accuracy of inserting implants [ Time Frame: 16 months after inclusion ] [ Designated as safety issue: No ]
  • Delay of mucous healing [ Time Frame: 16 months after inclusion ] [ Designated as safety issue: No ]
  • Estimation of the prosthetic function [ Time Frame: 16 months after inclusion ] [ Designated as safety issue: No ]
  • Osteonecrosis rate after radiation with traumatic etiology due to implantation [ Time Frame: 16 months after inclusion ] [ Designated as safety issue: No ]
  • Implant rate [ Time Frame: 16 months after inclusion ] [ Designated as safety issue: No ]
  • Post surgical therapeutic success after 1 year [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: September 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925509

Locations
France
Centre Léon Bérard Service de Chirurgie-Stomatologie
Lyon, Cedex 08, France, 69373
CHU Hôtel-Dieu Service d'Odontologie
Clermont-ferrand, France, 63 000
Hospices Civils de Lyon Service de Consultations et Traitements Dentaires
Lyon, France, 69007
Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale
Pierre Benite, France, 69495
Sponsors and Collaborators
Centre Leon Berard
French Academic Institution, Financial support: PHRC 2007
Investigators
Principal Investigator: Anne-Gaëlle BODARD, MD Centre Leon Berard
  More Information

Publications:

Responsible Party: Centre Leon BERARD, Unité de Biostatistiques et Evaluation des Thérapeutiques
ClinicalTrials.gov Identifier: NCT00925509     History of Changes
Other Study ID Numbers: ET2006-032, CPP 07/033 [UBET83]
Study First Received: June 2, 2009
Last Updated: June 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
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

ClinicalTrials.gov processed this record on September 30, 2014