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

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:

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

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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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 May 21, 2013

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