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Trial registered on ANZCTR


Registration number
ACTRN12609000304235
Ethics application status
Not yet submitted
Date submitted
14/04/2009
Date registered
19/05/2009
Date last updated
19/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Bronchoscopic detection of sentinel lymph node in non-small cell lung cancer: a feasibility study
Scientific title
A feasibility study in developing a novel technique for bronchoscopic detection of sentinel lymph node in non-small cell lung cancer patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small cell lung cancer 4590 0
Condition category
Condition code
Cancer 4884 4884 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bronchoscopic injection, via transbronchial needle introduced into submucosal layer of bronchial wall, of technetium-99 (antimony colloid) into region of lung in which lung cancer resides.
Intervention code [1] 4354 0
Diagnosis / Prognosis
Comparator / control treatment
None - feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5738 0
Identification of sentinel lymph node by non-invasive means using Nuclear Medicine imaging
Timepoint [1] 5738 0
24 hours after bronchoscopy
Secondary outcome [1] 241686 0
Safety: risk of pneumothorax
Mode of assessment of outcome: Routine chest x-ray will be performed after each procedure. clinical observatino for a minimum 4 hours post-procedure will also be routine
Timepoint [1] 241686 0
4 hours after bronchoscopy

Eligibility
Key inclusion criteria
patients undergoing flexible bronchoscopy for the diagnosis of suspected peripheral lung cancer
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient declines
Mediastinal lymphadenopathy on computerized tomography (CT) chest
medically unsuitable for bronchoscopy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Bronchoscopic injection of Technetium-99 into carina of lung lobe in which lung mass is stiuated will be performed following diagnostic sampling.
Single Photon Emission computerized tomography combined with conventional computerized tomography (SPECT/CT) chest will be performed in order to visualize drainage of radio-isotope to regional lymph nodes in order to identify sentinel node.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4776 0
Self funded/Unfunded
Name [1] 4776 0
Country [1] 4776 0
Australia
Primary sponsor type
Individual
Name
Daniel Steinfort
Address
c/- Dept Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3050
Country
Australia
Secondary sponsor category [1] 4314 0
None
Name [1] 4314 0
Address [1] 4314 0
Country [1] 4314 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6822 0
Ethics committee address [1] 6822 0
Ethics committee country [1] 6822 0
Date submitted for ethics approval [1] 6822 0
24/04/2009
Approval date [1] 6822 0
Ethics approval number [1] 6822 0

Summary
Brief summary
This study looks at the feasibility of using Technitium, injected via a bronchoscope, for the detection of the sentinel lymph node in suspected non-small cell lung cancer

Who is it for?
You can join this study if you are: - about to undergo flexible bronchoscopy for the diagnosis of suspected non-small cell lung cancer - 40-85 years of age - prepared to accept the 2% risk of developing a pneumothorax (collapsed lung) with this treatment.

Trial details
While having their scheduled bronchoscope, participants will receive injection of technetium dye into the region of the lung which has the lung cancer. The technetium will allow any sentinel lymph nodes to be identified by a non-invasive Nuclear Medicine imaging test called a SPECT/CT scans, 4 hours after the injection. The study will look at the effectiveness and safety of this procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29483 0
Address 29483 0
Country 29483 0
Phone 29483 0
Fax 29483 0
Email 29483 0
Contact person for public queries
Name 12730 0
Dr Daniel Steinfort
Address 12730 0
c/- Dept Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3050
Country 12730 0
Australia
Phone 12730 0
+61 3 9342 7708
Fax 12730 0
Email 12730 0
[email protected]
Contact person for scientific queries
Name 3658 0
Dr Daniel Steinfort
Address 3658 0
c/- Dept Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3050
Country 3658 0
Australia
Phone 3658 0
+61 3 9342 7708
Fax 3658 0
Email 3658 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.