Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer

NCT00003654 | Terminated

• 3 other identifiers: CDR0000066746FRE-FNCLCC-96008EU-98055
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors. PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Interventions

patent blue V dye DRUG

lymphangiography PROCEDURE

radionuclide imaging PROCEDURE

sentinel lymph node biopsy PROCEDURE

technetium Tc 99m sulfur colloid RADIATION

Eligibility Criteria

• Age: 0 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I or IIA invasive breast cancer T0, T1, or T2 (no greater than 3 cm), N0 Noninflammatory Nonmetastatic No ductal carcinoma in situ Eligible for breast-conserving surgery Hormone receptor status: Positive or negative PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Pre- and postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No allergy or sensitivity to radiopharmaceuticals or patent blue V dye PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior neoadjuvant radiotherapy Surgery: No prior breast surgical biopsy or axillary surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (1)

Centre Paul Strauss

Strasbourg, 67085, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

iso-sulfan blue; Sentinel Lymph Node Biopsy; Technetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques; Sulfur Compounds; Inorganic Chemicals; Technetium Compounds

Study Officials

• Jean-Francois Rodier, MD

  Centre Paul Strauss

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 26, 2004
• Study Start: September 1, 1997
• Primary Completion: January 1, 2000
• Study Completion: January 1, 2000
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

FR (1)