Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer

French Randomized Sentinel Node Multicentric Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00052676

Enrollment

Unknown

Registered

2003-01-27

Start date

2002-10-31

Completion date

2007-05-31

Last updated

2013-05-15

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

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer

Brief summary

RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer. PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.

Detailed description

OBJECTIVES: * Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification. * Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs. * Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid. * Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection. Patients are followed for disease evolution. PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.

Interventions

DRUGpatent blue V dye

PROCEDUREradionuclide imaging

PROCEDUREsentinel lymph node biopsy

RADIATIONtechnetium Tc 99m sulfur colloid

Study design

Allocation

RANDOMIZED

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive breast cancer * T0, T1, or T2 no greater than 3 cm, N0 * Amenable to surgery * No inflammatory breast cancer * No ductal cancer in situ or multicentric invasive ductal cancer * No nipple/areola or central breast cancer (at least 2 cm from areola) * No metastatic disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Not specified Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant * Negative pregnancy test * No known allergy or intolerance to patent blue V dye PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * No prior surgery for cancer Other * No prior neoadjuvant treatment for cancer

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026