Technetium Tc 99m Sulfur Colloid and Blue Dye In Detectin... | NCT00052676

ID	Type	Description	Link
CDR0000258612	Registry Identifier	PDQ (Physician Data Query)
EU-20214

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Jan 24, 2003

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2013

Last Update Posted Date

May 15, 2013Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean-Francois Rodier, MD	Centre Paul Strauss	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Tivoli		Bordeaux		F-33030	France
Centre Jean Perrin

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17485709	Result	Rodier JF, Velten M, Wilt M, Martel P, Ferron G, Vaini-Elies V, Mignotte H, Bremond A, Classe JM, Dravet F, Routiot T, de Lara CT, Avril A, Lorimier G, Fondrinier E, Houvenaeghel G, Avigdor S. Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial. J Clin Oncol. 2007 Aug 20;25(24):3664-9. doi: 10.1200/JCO.2006.08.4228. Epub 2007 May 7.

Name	Type	Description	Arm Group Labels	Other Names
patent blue V dye	Drug
radionuclide imaging	Procedure
sentinel lymph node biopsy	Procedure
technetium Tc 99m sulfur colloid	Radiation

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
C025484	iso-sulfan blue
D021701	Sentinel Lymph Node Biopsy
D013671	Technetium Tc 99m Sulfur Colloid

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013048	Specimen Handling
D003949	Diagnostic Techniques, Surgical
D013514	Surgical Procedures, Operative
D008197	Lymph Node Excision
D008919	Investigative Techniques
D013457	Sulfur Compounds
D007287	Inorganic Chemicals
D017556	Technetium Compounds