Intraoperative Gamma Camera for Breast Cancer Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Institut Pluridisciplinaire Hubert Curien. UMR 7178 - CNRS/IN2P3
ULP. F-67037 Strasbourg
National Cancer Institute, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00757302
First received: September 22, 2008
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Ductal Carcinoma in Situ
Device: SLN procedure (CarolIReS camera)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Proportion of subjects for which the gamma camera can detect sentinel lymph nodes (SLN) not identified by other technic. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with at least one additional sentinel lymph nodes (SLN) detected by preoperative pictures with gamma camera. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of subjects with at least one additional sentinel lymph nodes (SLN) detected by the pictures with gamma camera to intervene. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: September 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
For the first 10 patients, only a pre-operative procedure will be performed.
Device: SLN procedure (CarolIReS camera)

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).

Other Name: gamma camera carolires in detection on sentinel lymph node
Experimental: II
The last 100 patients will receive the complete procedure.
Device: SLN procedure (CarolIReS camera)

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).

Other Name: gamma camera carolires in detection on sentinel lymph node

Detailed Description:

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). During surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be measured immediately after their resection by a gamma ray counter and they will then be submitted to pathological analysis with frozen section.

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). During surgery, the search for radioactive nodes will be performed using the CarolIReS probe. In order to evaluate the CarolIReS camera sensitivity, the activity of the removed SLNs will be measured immediately after their resection by a gamma ray counter and they will then be submitted to pathological analysis with frozen section. After SLN removal and during the pathological analysis, the axillary area will once again be checked using the CarolIReS camera (followed by a further surgical excision in the case of remaining SLNs).

When the pathological analysis will diagnose a metastatic SLN, complete axillary lymph node dissection (ALND) will immediately be performed. In the case of negative SLN, serial sections and detection of cytokeratine (AE1/AE3; Dako, Zymed, CA, USA) will be performed during standard pathological analysis. Macrometastases will be defined as clusters of cancer cells ≥2 mm, micrometastases as clusters of cancer cells ≥0.2 mm and <2 mm, and isolated cancer cells as clusters of cancer cells <0.2 mm. ALND will be performed in cases of macro- or micrometastases.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757302

Contacts
Contact: MATHELIN Carole, MD 33388116071 carole.mathelin@chru-strasbourg.fr

Locations
France
CHRU, Hôpital Civil ,Service de Gynécologie-obstétrique Recruiting
Strasbourg, France, 67091
Contact: MATHELIN Carole, MD    33388116071    carole.mathelin@chru-strasbourg.fr   
Principal Investigator: MATHELIN Carole, MD         
Sub-Investigator: GHARBI Mousselim, MD         
Sub-Investigator: LIEGOIS Philippe, MD         
Sub-Investigator: GRUCKER Daniel, MD         
Sub-Investigator: CROCE Sabrina, MD         
Sub-Investigator: MEHL Jean-Louis, MD         
Sub-Investigator: SCHAEFFER Roland, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Institut Pluridisciplinaire Hubert Curien. UMR 7178 - CNRS/IN2P3
ULP. F-67037 Strasbourg
National Cancer Institute, France
Investigators
Principal Investigator: MATHELIN Carole, MD
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00757302     History of Changes
Other Study ID Numbers: 4126
Study First Received: September 22, 2008
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
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.

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Skin Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on October 01, 2014