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

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ClinicalTrials.gov Identifier: NCT00925509
Recruitment Status : Terminated (Insufficient recruitment, too much selective inclusion criteria, feasibility problems)
First Posted : June 22, 2009
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
French Academic Institution, Financial support: PHRC 2007
Information provided by:
Centre Leon Berard

Brief 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.

Condition or disease Intervention/treatment Phase
Upper Digestive Tract Cancer Procedure: Therapeutic assessment -Radio-surgical guidance. Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

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.



Primary Outcome Measures :
  1. Accuracy of implants insertion, radio-surgical guidance. [ Time Frame: 8 months after inclusion ]

Secondary Outcome Measures :
  1. Accuracy of inserting implants [ Time Frame: 16 months after inclusion ]
  2. Delay of mucous healing [ Time Frame: 16 months after inclusion ]
  3. Estimation of the prosthetic function [ Time Frame: 16 months after inclusion ]
  4. Osteonecrosis rate after radiation with traumatic etiology due to implantation [ Time Frame: 16 months after inclusion ]
  5. Implant rate [ Time Frame: 16 months after inclusion ]
  6. Post surgical therapeutic success after 1 year [ Time Frame: after 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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]
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

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