Pulmonary NeoplasmsNCT00241267
Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease
An observational study of Pulmonary Neoplasms, run by University Hospital, Tours at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Neoplasms
- What is being tested?
- Dedicated ultrasonographic probe during bronchoscopy
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to Mar 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assumed proximal neoplastic pulmonary pathology
- Planned bronchoscopy and biopsy
Who cannot join
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pulmonary Neoplasms
- Being tested
- Dedicated ultrasonographic probe during bronchoscopy
- Keywords
- Pulmonary, Neoplasms, Endobronchial, Ultrasonography, Primary
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated ultrasonographic probe during bronchoscopyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startMar 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- François TRANQUART, PR, Principal investigator, Centre d'Innovation Technologique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241267
- Sponsor's protocol ID
- CT04-FT/ENDO
- Status last verified
- May 2006
- First submitted
- 14 Oct 2005
- Last updated
- 6 Oct 2006
- Results posted
- No
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. doi: 10.1378/chest.126.3.959.
PubMed 15364779Baba 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. doi: 10.1016/s0169-5002(01)00284-7.
PubMed 11750715Falcone F, Fois F, Grosso D. Endobronchial ultrasound. Respiration. 2003 Mar-Apr;70(2):179-94. doi: 10.1159/000070066.
PubMed 12740516
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease
- ClinicalTrials.gov ID
- NCT00241267
- Acronym / sponsor ID
- CT04-FT/ENDO
- Conditions
- Pulmonary Neoplasms
- Keywords
- Pulmonary, Neoplasms, Endobronchial, Ultrasonography, Primary
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Mar 2006
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Assumed proximal neoplastic pulmonary pathology
- Planned bronchoscopy and biopsy
Key exclusion criteria (2 listed)
- Pregnancy
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dedicated ultrasonographic probe during bronchoscopy | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2006.
- Background: PubMed 15364779Kurimoto 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. doi: 10.1378/chest.126.3.959.
- Results publication: PubMed 11750715Baba 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. doi: 10.1016/s0169-5002(01)00284-7.
- Results publication: PubMed 12740516Falcone F, Fois F, Grosso D. Endobronchial ultrasound. Respiration. 2003 Mar-Apr;70(2):179-94. doi: 10.1159/000070066.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François TRANQUART, PR principal investigator
Centre d'Innovation Technologique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Neoplasms, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00241267, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2006.