Know Cancer

or
forgot password

Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Ductal Carcinoma in Situ

Thank you

Trial Information

Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

MATHELIN Carole, MD

Investigator Role:

Principal Investigator

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

4126

NCT ID:

NCT00757302

Start Date:

September 2008

Completion Date:

September 2014

Related Keywords:

  • Breast Cancer
  • Ductal Carcinoma In Situ
  • 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.
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location