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Sentinel node biopsy adding indocyanine green injection at the tumor/biopsy site during the surgical procedure to the standard technique (blue die and lymph scintigraphy) and near infra red light for fluorescence. The indocyanine green saline solution - 5mg diluted in 10ml. will be injected in 4 points around the biopsy site - 4ml each - total 0.8mg - single procedure.Near infra red lens and camera will be used to detect the fluorescence and localize the sentinel node for biopsy.

Near infra red sentinel node biopsy

Indocyanine green

Intraoperative Near-Infrared Imaging System

Camila Crovador

Vinicius L Vazquez, Ph.D.

Vinicius L Vazquez, Ph.D

Carlos EB Carvalho, M.D.

Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.

The main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. The fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. Patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. Immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (NIR) is focused over it. An appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. The skin is opened and the sentinel node is resected. The success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. All sentinel node characteristics are noted as number, which technic identified it, time, location. Later information will be gathered as histological status, surgical complications, recurrence and survival.

Fluorescence Surgery for Sentinel Node Identification in Melanoma

Infrared Fluorescence Guided Surgery for Sentinel Node Identification in Cutaneous Melanoma

Presence and time to disease recurrence or not

The successful rate of the sentinel node localization and biopsy. The standard technique and the experimental one will be assessed

The false negative sentinel node biopsy rate. The proportion of patients submitted to the procedure with histological negative biopsy, presenting lymph node metastasis at follow up.

Barretos Cancer Hospital

Breast Neoplasms

Breast Diseases

No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases

Omission of axillary clearance

Jana M de Boniface, MD, PhD

Jan Frisell, Professor

Leif Bergkvist, Professor

Yvette Andersson, MD, PhD

Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone results in significantly less arm discomfort following the operation.

However, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither SN biopsy nor axillary clearance), or without completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show any differences in 5-year disease-free survival between patients with SN micrometastases who had undergone ALND and those who had not.

This Swedish multicenter study will include patients with SN micrometastases. These women will not undergo ALND but will be registered in a study cohort. The patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival.

From April 2017 onwards, only patients operated by mastectomy or those receiving neoadjuvant therapy and having a sentinel node biopsy before its initiation may be recruited into SENOMIC. The inclusion target has been met for those patients operated by breast-conserving therapy, and from now on, these patients will not be included in SENOMIC anymore. Recruitment of the above-mentioned patient selection will continue until 452 patients operated by mastectomy have been enrolled.

Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis

Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study

Centrallasarettet Västerås

Uppsala University

Karolinska Institutet

MD, PhD

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Molecular biologic detection of micrometastases in lymph nodes of patients with localized prostate cancer treated with radical prostatectomy and lymphadenectomy.

tumor marker detection in lymph nodes by quantitative PCR

tumor marker detection in lymph nodes

The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes of patients with prostate cancer by quantitative polymerase chain reaction and its impact on progression-free survival.

Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Influence of molecularbiologic micrometastases in lymph nodes on biochemical recurrence free survival in comparison with patients who have histopathologic macrometastases or no evidence of lymph node metastases

Description of the anatomic distribution of molecularbiologic lymph node micrometastases in prostate cancer patients treated with radical prostatectomy and extended lymphadenectomy.

The frequency of molecular detected lymph node micrometastases according to their anatomic distribution at the obturatoric fossa, external iliac, internal iliac and common iliac arteries´ region will be reported.

Technical University of Munich

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluorescence Surgery for Sentinel Node Identification in Melanoma	NCT02142244	Melanoma Lymph Node Meta...	Near infra red ... Indocyanine gre... Intraoperative ...	18 Years -	Barretos Cancer Hospital
Fluorescence Surgery for Sentinel Node Identification in Melanoma	NCT02142244	Melanoma Lymph Node Meta...	Near infra red ... Indocyanine gre... Intraoperative ...	18 Years -	Barretos Cancer Hospital
Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis	NCT02049632	Breast Cancer	Omission of axi...	18 Years -	Karolinska Institutet
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer	NCT01615965	Prostate Cancer	tumor marker de...	18 Years - 80 Years	Technical University of Munich

Spots Global Cancer Trial Database for micrometastasis