Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease - Full Text View

Sponsored by:	University Hospital, Tours
Information provided by:	University Hospital, Tours
ClinicalTrials.gov Identifier:	NCT00241267

Purpose

The exploration of neoplastic pulmonary pathology is based on computed tomography and bronchoscopy. This allows targeted samples of the identified lesions.

A new ultrasonographic method is proposed as a non invasive and non irradiating technic by using a dedicated probe easily introduced via the channel of the fibrescope, so as to complete the identification of peripheral lesions.

Condition	Intervention
Pulmonary Neoplasms	Device: Dedicated ultrasonographic probe during bronchoscopy

MedlinePlus related topics: Cancer Lung Cancer Ultrasound

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

Further study details as provided by University Hospital, Tours:

Estimated Enrollment:	20
Study Start Date:	March 2005
Estimated Study Completion Date:	March 2006

Detailed Description:

The main objective of the study is to assess the ability of endobronchial ultrasonography to diagnose peripheral pulmonary lesions during the bronchoscopy and to correlate the abnormalities to computed tomography and/or histology.

The dedicated probe consist of a linear array of 2-3 mm in diameter connected to a commercial unit.

Eligibility

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

Criteria

Inclusion Criteria:

Assumed proximal neoplastic pulmonary pathology
Planned bronchoscopy and biopsy

Exclusion Criteria:

Pregnancy
Breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241267

Locations

France
University Hospital of TOURS
TOURS, France, 37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator:

François TRANQUART, PR

Centre d'Innovation Technologique

More Information

Publications of Results:

Baba M, Sekine Y, Suzuki M, Yoshida S, Shibuya K, Iizasa T, Saitoh Y, Onuma EK, Ohwada H, Fujisawa T. Correlation between endobronchial ultrasonography (EBUS) images and histologic findings in normal and tumor-invaded bronchial wall. Lung Cancer. 2002 Jan;35(1):65-71.

Falcone F, Fois F, Grosso D. Endobronchial ultrasound. Respiration. 2003 Mar-Apr;70(2):179-94. Review.

Other Publications:

Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65.

Study ID Numbers:	CT04-FT/ENDO
Study First Received:	October 14, 2005
Last Updated:	October 5, 2006
ClinicalTrials.gov Identifier:	NCT00241267
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Tours:

Pulmonary
Neoplasms
Endobronchial
Ultrasonography
Primary

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009