The value of Isosulfan Blue dye in addition to Isotope scan in Sentinel lymph Node biopsy for breast cancer patients with a positive lymphoscintigraphy.

ISRCTN	ISRCTN98849733
DOI	https://doi.org/10.1186/ISRCTN98849733
Protocol serial number	N/A
Sponsor	St. Vincent's University Hospital (Ireland)
Funder	St. Vincent's University Hospital (Ireland) - Department of Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Enda McDermott
Scientific

St. Vincent's University Hospital
Elm Park
Dublin
4
Ireland

Primary study design	Interventional
Study design	Randomised open-label controlled parallel-group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethics and Medical Research Committee of St. Vincent's University Hospital, 16/02/2010, ref: 16/02/10
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The effect of the omission of the blue dye on the identification of SLN if the scintigram is positive
Key secondary outcome measure(s)	1. Complications from the blue dye including tattoo of the skin 2. Cost effectiveness
Completion date	01/03/2012

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	734
Key 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
Key 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
Date of first enrolment	01/03/2010
Date of final enrolment	01/03/2012

St. Vincent's University Hospital

Dublin
4
Ireland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2015		Yes	No
Abstract results	results	01/12/2013		No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes