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 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/05/2010
- Registration date
- 18/06/2010
- Last edited
- 31/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Enda McDermott
Scientific
Scientific
St. Vincent's University Hospital
Elm Park
Dublin
4
Ireland
Study information
| Study design | Randomised open-label controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/03/2010 |
| Completion date | 01/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Ireland
Study participating centre
St. Vincent's University Hospital
Dublin
4
Ireland
4
Ireland
Sponsor information
St. Vincent's University Hospital (Ireland)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
Elm Park
Dublin
4
Ireland
"ROR" |
https://ror.org/029tkqm80 |
|---|
Funders
Funder type
Hospital/treatment centre
St. Vincent's University Hospital (Ireland) - Department of Surgery
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results | 01/12/2013 | No | No | |
| Results article | results | 01/08/2015 | Yes | No |
