Clinical trial · Interventional
Intraoperative Gamma Camera for Breast Cancer Surgery
Evaluation of a New Intraoperative Gamma Camera for the Sentinel Lymph Node Procedure in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SLN procedure (CarolIReS camera) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- I
- description
- For the first 10 patients, only a pre-operative procedure will be performed.
- interventionNames
- Device: SLN procedure (CarolIReS camera)
- type
- EXPERIMENTAL
- label
- II
- description
- The last 100 patients will receive the complete procedure.
- interventionNames
- Device: SLN procedure (CarolIReS camera)
Primary outcomes (1)
- measure
- Proportion of subjects for which the gamma camera can detect sentinel lymph nodes (SLN) not identified by other technic.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTMathelin 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