Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients will intraoperatively receive a transanal local administration of ICG. During laparoscopic total mesorectal excision, ICG-fluorescent lymph nodes beyond the mesorectum will be separately excised and sent for pathology

Excision of ICG-fluorescent lymph nodes in addition to standard laparoscopic total mesorectal excision in rectal cancer patients after neoadjuvant chemoradiation

ICG-guided lymphadenectomy

Luca Sorrentino, MD

Maurizio Cosimelli, MD

Luigi Battaglia, MD

Marcello Guaglio, MD

Gaia Colletti, MD

The goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The main questions it aims to answer are:

* Does the use of ICG increase the total number of harvested lymph nodes?
* Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes?

Participants will intraoperatively receive a trans-anal administration of ICG near to rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. A comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of ICG.

Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Breast Neoplasms

Lymphedema

Application of axillary mapping reverse technique

At the time of performing the ALND associate the ARM, injecting between 2-5mL of indocyanine green subcutaneously in the ipsilateral upper extremity at the medial inter-muscular and massaged for 5 min. First, identify the ARM nodes by indocyanine green, then perform conventional axillary lymphadenectomy trying to preserve the ARM nodes. And, in a second time, extract ARM nodes for their individualized anatomopathological study.

Axillary mapping reverse

Carlos Ortega Expósito, MD

The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.

Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.

In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.

HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.

This is a prospective not randomized pilot study to validate the axillary mapping reverse technique by using indocyanine green.

Axillary Reverse Mapping in Breast Cancer

Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery

Determinate the percentage of patients who is possible preserve the ARM node during ALND

Determinate the percentage of metastatic ARM nodes.

Hospital Universitari de Bellvitge

Principal Investigator

Oligometastatic patients with abdominal-pelvic lymph nodes

Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases

Ciro Franzese, MD

This is a prospective, multicentric, phase II and feasibility study aimed to address early and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.

The purpose of this prospective, multicentric, phase II study is to determine the feasibility of Stereotactic Body Radiation Therapy in stage IV selected oligometastatic patients, by looking at acute and late toxicity. Investigators also want to verify what is the impact of local control in irradiated metastatic foci in the context of the systemic disease, how local control can affect disease free survival and overall survival, and moreover quality of life of patients treated.

High Dose SBRT for Abdominal-Pelvic Lymph Nodal Lesions in Oligometastatic Patients

Feasibility Study of High Dose Stereotactic Body Radiation Therapy (SBRT) for Lymph Nodal Lesions in Oligometastatic Patients for Genito-urinary, Gastro-intestinal and Gynaecological Cancer

Evaluation of acute and late toxicity performed during and after radiation therapy

Evaluation of tumour response to local radiation therapy by means of imaging

Statistical evaluation of how local control of the metastatic disease can affect overall survival

Statistical evaluation of how local control of the metastatic disease can affect disease free survival

Evaluation of quality of life of patients during and after radiation therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy	NCT05873621	Rectal Cancer Lymph Node Canc...	ICG-guided lymp...	18 Years - 90 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Axillary Reverse Mapping in Breast Cancer	NCT05040685	Lymph Node Canc...	Axillary mappin...	18 Years -	Hospital Universitari de Bellvitge
High Dose SBRT for Abdominal-Pelvic Lymph Nodal Lesions in Oligometastatic Patients	NCT02570399	Lymph Node Canc...	Oligometastatic...	18 Years -	Istituto Clinico Humanitas

Spots Global Cancer Trial Database for lymph node cancer metastatic