Intraoperative Gamma Camera for Breast Cancer Surgery

NCT00757302 | Completed Phase 3

• 1 other identifier: 4126
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: This study aims at evaluating the performances of an intraoperative gamma camera (field of view 10X10 cm), named CarolIReS, to detect axillary drainage and to assess the removal of sentinel lymph nodes (SLN) in breast surgery. Patients and Methods: SLN biopsy will be performed on 110 patients and the CarolIReS camera will be used preoperatively to localize SLNs. During surgery, individual removal of SLNs will be performed using a gamma probe named CarolIReS and their activity will be measured with a gamma ray counter. At the end of surgery, the CarolIReS camera will be used again to check the quality of surgery which will be followed by a surgical excision in case of remaining SLNs. Objectives: The main objective of this study is to evaluate the performances of the CarolIReS camera in assessing the axillary drainage of breast tumors and the surgical removal of SLNs. In addition, the possible correlation between the activity, the size, and the metastatic involvement of the SLNs will also be studied.Study hypothesis: Intraoperative cameras could be used to improve the efficiency of the SLN procedure

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Keywords

breast cancer; CarolIReS; intraoperative gamma camera; lymphoscintigraphy; sentinel lymph node; Hundred and ten patients with infiltrative breast cancer or ductal carcinoma in situ (DCIS), diagnosed preoperatively by core biopsy or cytology.

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects for which the gamma camera can detect sentinel lymph nodes (SLN) not identified by other technic.

  1 year

Secondary Outcomes (2)

• Proportion of subjects with at least one additional sentinel lymph nodes (SLN) detected by preoperative pictures with gamma camera.

  1 year

• Proportion of subjects with at least one additional sentinel lymph nodes (SLN) detected by the pictures with gamma camera to intervene.

  1 year

Study Arms (2)

I

EXPERIMENTAL

For the first 10 patients, only a pre-operative procedure will be performed.

Device: SLN procedure (CarolIReS camera)

II

EXPERIMENTAL

The last 100 patients will receive the complete procedure.

Device: SLN procedure (CarolIReS camera)

Interventions

SLN procedure (CarolIReS camera) DEVICE

Group I : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²). Group II : The SLN procedure will be initiated 18 hours before surgery using a preoperative injection of colloidal rhenium sulphur and technetium (0.4 ml, 20 MBq of Nanocis®; CIS Bio International, France) at the four cardinal points in the subareolar area. Lymphoscintigraphy will be obtained 3 hours after the injection. Immediately before surgery, the axillary drainage will be checked using the CarolIReS camera (FOV 10x10 cm²).

Also known as: gamma camera carolires in detection on sentinel lymph node

I; II

Eligibility Criteria

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

You may qualify if:

• Patient major at the time of breast surgery.
• Patient affiliated with a social security.
• Consent dated and signed by the investigator and the subject.
• Subject having been informed of the sentinel lymph node procedure during the visit prior to breast surgery.
• Patient having a unifocal infiltrative breast cancer (less than 2 cm) diagnosed preoperatively by core biopsy or cytology.
• Patient having a ductal carcinoma in situ (DCIS), diagnosed preoperatively by core biopsy or cytology.

You may not qualify if:

• Refusal of the patient to be included in the study.
• Pregnant patient or during breastfeeding.
• None of the patients will have undergone chemotherapy, locoregional radiotherapy or prevalent axillary lymph node.
• Diagnosed safeguarding justice and trust.
• Patient with a psychiatric disorder makes it impossible for the collection of informed consent-patient with tumors greater than 2 cm or multifocal.
• Prevalent axillary lymph node.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• Institut Pluridisciplinaire Hubert Curien. UMR 7178 - CNRS/IN2P3: collaborator
• ULP. F-67037 Strasbourg: collaborator
• National Cancer Institute, France: collaborator

Study Sites (1)

CHRU, Hôpital Civil ,Service de Gynécologie-obstétrique

Strasbourg, 67091, France

Location

Related Publications (1)

• Mathelin C, Salvador S, Bekaert V, Croce S, Andriamisandratsoa N, Liegeois P, Prados E, Guyonnet JL, Grucker D, Brasse D. A new intraoperative gamma camera for the sentinel lymph node procedure in breast cancer. Anticancer Res. 2008 Sep-Oct;28(5B):2859-64.

  PMID: 19031925 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• MATHELIN Carole, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)