Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts (ATIM)
21 juni 2011 bijgewerkt door: Centre Leon Berard
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.
Studie Overzicht
Toestand
Beëindigd
Interventie / Behandeling
Gedetailleerde beschrijving
- 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
Studietype
Ingrijpend
Inschrijving (Verwacht)
53
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Clermont-ferrand, Frankrijk, 63 000
- CHU Hôtel-Dieu Service d'Odontologie
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Lyon, Frankrijk, 69007
- Hospices Civils de Lyon Service de Consultations et Traitements Dentaires
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Pierre Benite, Frankrijk, 69495
- Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale
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Cedex 08
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Lyon, Cedex 08, Frankrijk, 69373
- Centre Léon Bérard Service de Chirurgie-Stomatologie
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Accuracy of implants insertion, radio-surgical guidance.
Tijdsspanne: 8 months after inclusion
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8 months after inclusion
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Accuracy of inserting implants
Tijdsspanne: 16 months after inclusion
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16 months after inclusion
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Delay of mucous healing
Tijdsspanne: 16 months after inclusion
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16 months after inclusion
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Estimation of the prosthetic function
Tijdsspanne: 16 months after inclusion
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16 months after inclusion
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Osteonecrosis rate after radiation with traumatic etiology due to implantation
Tijdsspanne: 16 months after inclusion
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16 months after inclusion
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Implant rate
Tijdsspanne: 16 months after inclusion
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16 months after inclusion
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Post surgical therapeutic success after 1 year
Tijdsspanne: after 1 year
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after 1 year
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Anne-Gaëlle BODARD, MD, Centre Leon Berard
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
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- Gill SS, Thomas DG, Warrington AP, Brada M. Relocatable frame for stereotactic external beam radiotherapy. Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):599-603. doi: 10.1016/0360-3016(91)90076-g.
- Gulizio MP, Agar JR, Kelly JR, Taylor TD. Effect of implant angulation upon retention of overdenture attachments. J Prosthodont. 2005 Mar;14(1):3-11. doi: 10.1111/j.1532-849X.2005.00005.x.
- Henderson LA, Frysinger RC, Yu PL, Bandler R, Harper RM. A device for feline head positioning and stabilization during magnetic resonance imaging. Magn Reson Imaging. 2001 Sep;19(7):1031-6. doi: 10.1016/s0730-725x(01)00423-4.
- Kamath R, Ryken TC, Meeks SL, Pennington EC, Ritchie J, Buatti JM. Initial clinical experience with frameless radiosurgery for patients with intracranial metastases. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1467-72. doi: 10.1016/j.ijrobp.2004.08.021.
- Kassaee A, Das IJ, Tochner Z, Rosenthal DI. Modification of Gill-Thomas-Cosman frame for extracranial head-and-neck stereotactic radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Nov 15;57(4):1192-5. doi: 10.1016/s0360-3016(03)00774-0.
- Marunick MT, Leveque F. Osteoradionecrosis related to mastication and parafunction. Oral Surg Oral Med Oral Pathol. 1989 Nov;68(5):582-5. doi: 10.1016/0030-4220(89)90244-2.
- Medin PM, Solberg TD, De Salles AA, Cagnon CH, Selch MT, Johnson JP, Smathers JB, Cosman ER. Investigations of a minimally invasive method for treatment of spinal malignancies with LINAC stereotactic radiation therapy: accuracy and animal studies. Int J Radiat Oncol Biol Phys. 2002 Mar 15;52(4):1111-22. doi: 10.1016/s0360-3016(01)02762-6.
- Parel SM, Triplett RG. Interactive imaging for implant planning, placement, and prosthesis construction. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):41-7. doi: 10.1016/j.joms.2004.05.207.
- Quinones-Hinojosa A, Ware ML, Sanai N, McDermott MW. Assessment of image guided accuracy in a skull model: comparison of frameless stereotaxy techniques vs. frame-based localization. J Neurooncol. 2006 Jan;76(1):65-70. doi: 10.1007/s11060-005-2915-z.
- Rosenberg I, Alheit H, Beardmore C, Lee KS, Warrington AP, Brada M. Patient position reproducibility in fractionated stereotactic radiotherapy: an update after changing dental impression material. Radiother Oncol. 1999 Feb;50(2):239-40. doi: 10.1016/s0167-8140(99)00002-x.
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- Watzinger F, Ewers R, Henninger A, Sudasch G, Babka A, Woelfl G. Endosteal implants in the irradiated lower jaw. J Craniomaxillofac Surg. 1996 Aug;24(4):237-44. doi: 10.1016/s1010-5182(96)80007-2.
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- Weischer T, Mohr C. Implant-supported mandibular telescopic prostheses in oral cancer patients: an up to 9-year retrospective study. Int J Prosthodont. 2001 Jul-Aug;14(4):329-34.
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- Kooy HM, Dunbar SF, Tarbell NJ, Mannarino E, Ferarro N, Shusterman S, Bellerive M, Finn L, McDonough CV, Loeffler JS. Adaptation and verification of the relocatable Gill-Thomas-Cosman frame in stereotactic radiotherapy. Int J Radiat Oncol Biol Phys. 1994 Oct 15;30(3):685-91. doi: 10.1016/0360-3016(92)90956-i.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2007
Primaire voltooiing (Verwacht)
1 december 2011
Studie voltooiing (Verwacht)
1 december 2011
Studieregistratiedata
Eerst ingediend
2 juni 2009
Eerst ingediend dat voldeed aan de QC-criteria
19 juni 2009
Eerst geplaatst (Schatting)
22 juni 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
22 juni 2011
Laatste update ingediend die voldeed aan QC-criteria
21 juni 2011
Laatst geverifieerd
1 juni 2011
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- ET2006-032
- CPP 07/033 [UBET83]
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .