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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98849733

Enrollment

734

Registered

2010-06-18

Start date

2010-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Cancer Malignant neoplasm of breast

Interventions

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 recruitmen

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The effect of the omission of the blue dye on the identification of SLN if the scintigram is positive	—

Secondary

Measure	Time frame
1. Complications from the blue dye including tattoo of the skin 2. Cost effectiveness	—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026