Neoplasms

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Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Colonic Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Bevacizumab

Cola

Therefore this prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using peritumoral submucosal injections.

Sentinel lymph node identification

Esther Consten, prof. dr.

This prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using peritumoral submucosal injections

The current gold standard for the treatment of colon carcinoma consists of the surgical en-bloc resection of the colonic segment including the adjacent mesocolon containing the draining lymph nodes. Analysis of these lymph nodes is important, since lymph node status is one of the most important prognostic factors determining the use of adjuvant chemotherapy. Although patients with tumour stage I and II do not have lymph node metastases, 15-20% develop recurrent disease. Several studies suggest that ultrastaging techniques such as immunohistochemistry (IHC) or reverse transcriptase polymerase chain reaction (RT-PCR) using multilevel slicing results in upstaging of 14-18% of patients, due to newly found (micro)metastasis. Furthermore, several studies indicate that these micrometastases are correlated with a significantly poorer prognosis, subsequently suggesting that this subgroup of patients might benefit of adjuvant chemotherapy. Therefore, the most recent Dutch guidelines advice the use of adjuvant chemotherapy in this "upstaged" group, although evidence is still lacking.

However, ultrastaging techniques are labour-intensive and costly, and therefore not suitable for analyses of all lymph nodes that have been collected during segmental colectomy. Sentinel lymph node (SLN) identification in colon carcinoma has been proposed to overcome this problem by identifying the first order draining lymph node(s) of the tumour, which have the highest chance of containing metastatic tumour cells. Several studies aimed at SLN identification in colon carcinoma have been published, however, early studies using radio-guided or blue-dye guided SLN identification, showed relatively high rates of false negatives with consequent low sensitivity rates. Since mesocolon is rather fatty tissue, visualization of conventional dyes is difficult. Indocyanine green (ICG), which can be visualized using near infrared (NIR), has been put forward since it is known to penetrate relatively deep into living tissue.

Nevertheless, results of SLN identification using ICG remain unsatisfying with high false-negative rates and low sensitivity. Most likely this is due to the fact that these studies also included large cT3-cT4 tumours and patients with massive lymph node involvement. Which are factors known to interfere with lymph drainage patterns. Furthermore, subserosal injections were frequently used, while it is suggested that submucosal injections might result in better sensitivity of the procedure. In the FLUOR-SLN-ICG pilot study, we successfully conducted SLN identification in patients with ICG.

Recently, more research is conducted in tumour-targeted tracers as they have many advantages compared to ICG. For example, tumour-targeted tracers can be preoperatively administered which aid logistics, binds to tumour and metastases, thus allowing more time for uptake in patients with larger tumours and lymph node metastases. These properties may result in increased accuracy and would be more broadly applicable compared to ICG. Furthermore, tumour-targeted tracers can also be administrated intravenously and potentially identify lymph node metastases without having to perform a colonoscopy. However, administration via colonoscopy of tumour-targeted tracers for the detection of lymph node metastases in colon carcinoma has not been performed yet, and intravenous administration would be a step after administration via colonoscopy.

Therefore this prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using peritumoral submucosal injections.

This is a single-centre, open-label, non-randomized cohort safety and feasibility study.

Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.

A Pilot Study to Assess the Safety and Feasibility of Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.

Defined as the number of patients in which a SLN or lymph node metastases were detected due to fluorescence during surgery and/or pathology assessment divided by the total number of procedures.

We conclude that the study is a feasible if:

* We are to detect fluorescence in lymph nodes in 3 out of 5 patients (regardless of the presence of metastases)
* And/or we are able to detect lymph node metastases with fluorescence, or if fluorescence is higher in lymph node metastases compared to tumour-negative lymph nodes.

The rate of adverse events related to bevacizumab-800CW (injection) will be measured. This is defined as the number of adverse events related towards bevacizumab-800CW/total number of procedures.

Fluorescence measured in the Oddysey flatbed scanner

The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number).

Both the SLNs and NSNs are negative (number).

The number of patients with a positive SLN / the total number of node positive patients (n, %).

The number of patients with SLNs positive for micro- or macrometastases by serial slicing and IHC / the number of patients who were node negative by H\&E examination (n, %).

The number of patients with aberrant lymph nodes, and the status of these lymph nodes considering micro- or macrometastases.

(The total number of patients with a positive SLN + the number of patients with a true-negative SLN) / number of patients with an identified SLN (n, %).

The number of true negative SLNs / (true negative + false negative SLNs).

Meander Medical Center

prof. dr.

Mouth and Tooth Diseases

Rare Diseases

Carcinoma, Squamous Cell

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Micronutrients

Iron

Patients undergo routine sentinel lymph node procedure (99mTc injection, planar imaging, SPECT-CT and surgery) for clinical purposes. After 99mTc injections and imaging has been executed peritumoral SPIO injections are performed by a medical doctor. A T2\*-weighted iron sensitive MRI scan is made 1 hour later.

SPIO is peritumorally injected. A T2\*-weighted iron sensitive MRI scan is performed 1 hour later to localize and assess the sentinel lymph nodes.

SPIO-enhanced MRI

D.A.J.J. Driessen, MD

Daphne Driessen, Msc

J.H.A.M. Kaanders, MD, PhD

To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.

SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification

Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging for Sentinel Lymph Node Identification in Oral Cancer: a Feasibility Study

The first two patients will receive a dose of 0.012 ml SPIO. MR-images will be assessed. If this dose provides satisfactory MR-images (good visualization of lymph nodes without disturbing artefacts), subsequent patients will receive the same dose. If the artefact is too large, the dose will be decreased. If visualization is poor, the dose will be increased. The procedure will be repeated with adjusted doses each time in two patients until satisfactory MR-images are obtained.

The investigators have established timing of MRI 1 hour after SPIO injection. It is assumed that after this time interval SPIO particles have had sufficient time to migrate to the SNs and to be taken up. However, if this interval appears to be too long because 'too many' SNs are visualized the time interval will be shortened. If this interval appears to be too short since no or too little SNs are visualized because SPIO uptake has not taken place yet, the time interval will be lengthened.

SPIO-enhanced MR-images and SPECT-CT images are compared to investigate whether SPIO-enhanced MRI detects the same sentinel lymph nodes as SPECT-CT.

SNs will be localized on T2\* weighted SPIO-enhanced in vivo MR-images by a radiologist. Lymph node status will be assessed based on signal intensity. All surgically removed lymph nodes are embedded in a tissue cassette. Histopathological analysis of these lymph nodes includes multiple sectioning, HE staining, immunohistochemistry and iron staining. The MR-images are compared to the pathology slices to see whether the MR signal intensity pattern matches the benign/malignant structure of the lymph node.

Radboud University Medical Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Pharmaceutical Solutions

Methylene Blue

Enzyme Inhibitors

Intervention description: Intraoperative identification of sentinel lymph node

Intervention description: indocyanine green (5 to 10 mg \[ie, 2 to 4 mL of a 2.5 mg/mL solution\]) administered by periareolar or peritumoural route

indocyanine green

1%), 2-5 mL administered by periareolar or peritumoural route

methylene blue

(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route

Technetium (99mTc)

Céline Chauleur, MD

This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer.

The study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery.

The study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mTechnetium dye).

The study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye.

The study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.

A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.

French, Prospective, Post-marketing Study to Describe the Use, Detection Performance and Safety Profile of Infracyanine® (Indocyanine Green) for Breast Cancer Patients Undergoing a Sentinel Lymph Node (SLN) Biopsy.

Rate of detection of at least one sentinel lymph node by indocyanine green in obese (BMI ≥30 kg/m2) vs non-obese (BMI ≤30 kg/m2) patients

Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer

Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose

Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route

Rate of detection of at least one sentinel lymph node by indocyanine green

Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status)

Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc)

Route of injection (periareolar or peritumoural)

Equipment used for detection of sentinel lymph node

Number of sentinel lymph node biopsies performed

Time from injection to visualization of first sentinel lymph node

Time from injection to end of biopsy procedure

Number of sentinel lymph nodes detected (by all detection methods) per patient

Number of sentinel lymph nodes detected (by indocyanine green) per patient

Number of sentinel lymph nodes detected (by blue dye) per patient

Number of sentinel lymph nodes detected (by 99mTc) per patient

Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA

Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA

Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.	NCT05498051	Colonic Neoplas... Sentinel Lymph ... Fluorescence Colorectal Neop...	Sentinel lymph ...	18 Years -	Meander Medical Center
SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification	NCT04803331	Head and Neck S...	SPIO-enhanced M...	18 Years -	Radboud University Medical Center
A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.	NCT06024213	Breast Cancer	Sentinel lymph ... indocyanine gre... methylene blue Technetium (99m...	18 Years -	BTG International Inc.
A French Observational Study of Indocyanine Green for Patients With Breast Cancer Having a Sentinel Lymph Node Biopsy.	NCT06024213	Breast Cancer	Sentinel lymph ... indocyanine gre... methylene blue Technetium (99m...	18 Years -	BTG International Inc.

Spots Global Cancer Trial Database for sentinel lymph node identification