Condition category
Cancer
Date applied
13/05/2010
Date assigned
18/06/2010
Last edited
31/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Enda McDermott

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

St. Vincent's University Hospital (Ireland)

Sponsor details

Department of Surgery
Elm Park
Dublin
4
Ireland

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes