Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Under general anesthesia 5 ml at 2.5mg/ml of Infracyanine ® (Laboratoire SERB; France) were injected circumferentially around the areola. Two ml of patent blue-V dye (Laboratoire Guerbet, Aulney-Sous-Bois, France) were injected in combination in the cohort of patients undergoing the procedure after primary chemotherapy. This was followed by a breast massage to facilitate absorption into the lymph vessels, then the surgical lights were turned off and image were obtained under near-infrared light using a first generation Near Infra Red (NIR) device \[K\]. Course of subcutaneous lymphatic drainage pathway fluorescence was followed up to where it disappeared to enter to deeper axilla and an incision was performed at that place. Lymphatic duct identification using the NIR camera allowed localization and removal of the sentinel lymph node(s).

sentinel node detection

Samir Hidar, Prof. M.D

Background Radio Isotopes and Blue dye alone or in combination are the most commonly used tracer agents in sentinel Node Biopsy for early breast cancer. Recent studies have found fluorescence method using Indo Cyanine Green as a promising technology with fewer disadvantages. This study represents the first within a North African setting.

Methods Retrospective analysis of our database that includes patients with clinically node-negative breast cancer scheduled for breast surgery and SN biopsy between 2016 and January 2021. Patients who underwent detection using fluorescence-ICG were included in this study.

We performed a retrospective review our data base that includes breast cancer planned for sentinel node biopsy at the F. Hached University teaching hospital(Sousse, Tunisia). Data between April 2016 and January 2021 were reviewed. Only non-pregnant or lacting adult female patients without palpable clinical node and considered suitable for such procedure at multidisciplinary meeting were included. We excluded from our analysis the first ten cases considered as a learning curve Same operator (SH) carried out all the procedures.

Under general anesthesia 5 ml at 2.5mg/ml of Infracyanine ® were injected circumferentially around the areola. Two ml of patent blue-V dye (Laboratoire Guerbet, Aulney-Sous-Bois, France) were injected in combination in the cohort of patients undergoing the procedure after primary chemotherapy. This was followed by a breast massage to facilitate absorption into the lymph vessels, then the surgical lights were turned off and image were obtained under near-infrared light using a first generation Near Infra Red device . Course of subcutaneous lymphatic drainage pathway fluorescence was followed up to where it disappeared to enter to deeper axilla and an incision was performed at that place. Lymphatic duct identification using the NIR camera allowed localization and removal of the sentinel lymph node(s). Further fluorescent imaging was performed to identify potential residual signal in the axilla and such signal-sites were removed. Following ICG assisted-dissection, blue-stained nodes were excised if any. All detected sentinel node were send for frozen section and processed for histological examination. After sentinel node biopsy, conservative surgery or mastectomy were performed according to indication and axillary dissection was performed according to international guidelines.

Statistical analysis Baseline patient's and tumor characteristics, Identification Rate of the sentinel node with Indocyanine green and with dye , when used, were recorded. Data were entered and analyzed in Excel. The continuous variables are presented as mean ± standard deviation and categorical variables are presented as count and percentages unless specified. Informed consents from each patient and IRB approval were obtained

Indocyanine Green Fluorescence-guided Sentinel Node Biopsy in Breast Cancer Within a North African Population: a Retrospective Study

percentage of cas in whom sentinel node was identified with fluoresence method

Faculty of Medicine, Sousse

Prof. M.D

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

An ovarian lymphatic map will be performed in patients with adnexal masses suspected of malignancy. Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer confirmation including restaging surgeries.

Injection of the radiotracer to infundibulo-pelvic and utero-ovarian ligament in patients with high suspicion of malignancy adnexal mass. Injection of green indocyanine r to infundibulo-pelvic and utero-ovarian stumps only in case of malignancy after the adnexectomy.

Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer diagnosis.

Sentinel node detection

Núria Agustí, MD

Pilar Paredes, PhD

Núria Agustí Garcia, MD

Aureli Torné, PhD

Berta Díaz-Feijóo, PhD

Epithelial ovarian cancer (EOC) diagnosed in the initial stage (stage I-II) require complete staging surgery to histologically assess the possible existence of peritoneal or lymph node disease.

Systematic pelvic and paraaortic lymphadenectomy in stage I-II EOC is essential since confirming the presence of lymph node metastases means re-staging the disease as stage III. This change of stage has important prognostic and therapeutic implications. However, the lymph node involvement rate is around 10-30% (average of 15%). Systematic pelvic and para-aortic lymphadenectomy carries a risk of intraoperative complications, as well as longer operative time, postoperative complications and longer hospital stay. Moreover, by now there is no evidence suggesting a possible therapeutic value.

The sentinel lymph node (SLN) detects the first level of lymph node drainage. The absence of metastases in the SLN predicts the absence of tumor infiltration of the rest of lymph nodes of the same anatomical region and allows to safely avoid lymphadenectomy and its associated morbidity. In addition, the exhaustive evaluation of the SLN by ultrastaging and immunohistochemical study allows to increase the detection of microscopic disease.

Sentinel lymph node (SLN) biopsy, implemented in clinical practice in other gynecological tumors (breast, vulva, cervix or endometrium), has been studied very little in the initial ovarian epithelial cancer. Unlike other gynecological tumors, there are multiple anatomical and technical aspects that largely explain this lack of information. The double ovarian vascularization that accompanies lymphatic drainage explains this higher complexity. Therefore, at the present time, the detection of SLN in the initial EOC remains an experimental area without applicability in clinical practice. There are multiple doubts and issues to be resolved regarding the different tracers, the site and time injection and the actual accuracy of the SLN versus the lymphadenectomy.

The objective of this study is to know the lymphatic drainage and, if the lesion is malignant, remove the sentinel lymph nodes to know if it can predict the involvement of the remaining lymph nodes to assess the possible applicability of SLN in clinical practice.

Study design:

1. Evaluation of the ovarian lymphatic map: injection of radiotracer (99mTc-nanocolloid albumin) in patients with a diagnosis of adnexal mass with high suspicion of malignancy. Intraoperative lymphogammagraphy will be performed using a portable gammacamera. Patients with a delayed diagnosis of ovarian cancer who are candidates to undergo a re-staging surgery will be included.
2. After the adnexectomy a frozen section will be performed to confirm the diagnosis of malignancy and then the ICG (Indocyanine green) tracer will be injected. Since the spread and persistence of the ICG in the lymph nodes is rapid, this tracer will be injected only after confirmation of EOC. Simultaneous screening with a gammadetector probe and NIR (near-infrared spectrum) camera will be used to proceed to the detection of SLN according to the lymphatic map previously.
3. Ultrastaging of the SLN by applying hematoxylin and eosin staining (H\&E) and, in the absence of metastatic disease, evaluation by immunohistochemistry with cytokeratin AE1: AE3.

Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer

MELISA Trial: Mapping sEntinel Lymph Node in Initial StAges of Ovarian Cancer

The IPD will be shared only with those making official request to the study investigator

To check the ovarian lymphatic drainage in patients with suspected malignant adnexal masses

Detection of SLN in initial epithelial ovarian cancer by assessing the concordance of the result between the lymph node metastases and the lymphadenectomy

To know the global and specific SLN identification rate, depending on the type of tracer used.

The number of patients with tracer-related adverse events

Evaluate the existence of false negatives in metastatic involvement of the SLN and negative predictive value

The aortic and pelvic region will be divided 13 regions

Evaluate the performance of intraoperative lymphoscintigraphy with gamma-camera, gamma-probe and Infrared fluorescence camera in the visualization of the ovarian lymphatic map.

Evaluate the time it takes to perform the SLN technique

Evaluate if ultrastaging of the SLN improves the detection of micrometastases compared to conventional histology. Ultrastaging protocol will be performed, consisting of two consecutive histological sections (4 μm thick) obtained at regular intervals of 150 μm, performing 4 levels of each paraffin block. The first section will be stained with H\&E and the second section will be stained immunohistochemically with an AE1-AE3 anti-keratin antibody (Dako®).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Indocyanine Green Fluorescence-guided Sentinel Node Biopsy in Breast Cancer Within a North African Population: a Retrospective Study	NCT04879680	Breast Cancer Sentinel Lymph ...	sentinel node d...	20 Years -	Faculty of Medicine, Sousse
Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer	NCT05184140	Ovarian Cancer Sentinel Lymph ...	Sentinel node d...	18 Years -	Hospital Clinic of Barcelona
Indocyanine Green Fluorescence-guided Sentinel Node Biopsy in Breast Cancer Within a North African Population: a Retrospective Study	NCT04879680	Breast Cancer Sentinel Lymph ...	sentinel node d...	20 Years -	Faculty of Medicine, Sousse
Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer	NCT05184140	Ovarian Cancer Sentinel Lymph ...	Sentinel node d...	18 Years -	Hospital Clinic of Barcelona

Spots Global Cancer Trial Database for sentinel node detection