Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The value of Isosulfan Blue dye in addition to Isotope scan in Sentinel lymph Node biopsy for breast cancer patients with a positive lymphoscintigraphy: A randomised controlled trial
Acronym
Study hypothesis
Patients with breast cancer undergoing Sentinel lymph node biopsy (SLN) biopsy may not need the Isosulphan dye to identify the SLN if the node is/are identified on the lymphoscintigram when the radioisotope is used.
Ethics approval
Ethics and Medical Research Committee of St. Vincent's University Hospital, 16/02/2010, ref: 16/02/10
Study design
Randomised open-label controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Breast Cancer
Intervention
Patients going for SLN will have a lymphoscintigram. if the SLNs is identified the patients will be randomised to either receive or not receive the isosulphan blue dye.
The duration of the recruitment period will be 1.5-2 years. The total duration of follow up will be 2 months post intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The effect of the omission of the blue dye on the identification of SLN if the scintigram is positive
Secondary outcome measures
1. Complications from the blue dye including tattoo of the skin
2. Cost effectiveness
Overall trial start date
01/03/2010
Overall trial end date
01/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >18 years old and <90 years
2. Breast cancer (stages I, II and III) and a sentinel Lymph node biopsy is required as recommended at the multidisciplinary breast cancer meeting
3. A pre-operative lymphoscintigram with a single node or a few nodes present
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
734
Participant exclusion criteria
1. Age outside the inclusion criteria above
2. Stage IV breast cancer, and primary chemotherapy patients
3. Patients with negative scintigrams
4. Patients with a large number of nodes on the Scintigram >3 LNs
5. Patients who cannot give consent
Recruitment start date
01/03/2010
Recruitment end date
01/03/2012
Locations
Countries of recruitment
Ireland
Trial participating centre
St. Vincent's University Hospital
Dublin
4
Ireland
Funders
Funder type
Hospital/treatment centre
Funder name
St. Vincent's University Hospital (Ireland) - Department of Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://cancerres.aacrjournals.org/content/73/24_Supplement/P1-01-01.abstract
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25822674