Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Methylene Blue

Radiopharmaceuticals

Enzyme Inhibitors

Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.

Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.

Indocyanine green

Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.

Technetium99

Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.

Methylene blue

Colette Pameijer, MD

The initial treatment for most people with melanoma involves wide excision of the skin and sentinel node biopsy. As with other cancers, the status of the sentinel node provides important prognostic information to the patient and physician. Sentinel node biopsy was first developed using only a blue dye. Technetium99, a radioactive protein, was added later and provides the ability to image the patient and identify relevant lymph node basins. For the last 15 years or so, the standard method of SLN localization includes both tech99 and blue dye. While the rates of localization overall are excellent, these methods each have drawbacks. We are investigating a new method of finding sentinel nodes that uses a green dye that has an infrared signal. Our hypothesis is that indocyanine green (ICG) and real time lymphangiography is equivalent to technetium99 and methylene blue in identifying sentinel nodes (SLN) in patients with melanoma.

Patients with melanoma of the trunk or extremities were prospectively enrolled in this trial. Patients with head and neck melanoma were excluded from this study based on our pilot experience. ICG is poorly visualized through muscle, and there seems to be high background uptake in the parotid gland; both of these features limit the utility of ICG and fluorescence imaging. All subjects had T1b or greater melanoma, and met current National Comprehensive Cancer Network (NCCN) guidelines for sentinel node biopsy. All subjects had injection of tech99 and lymphangiography prior to surgery, and injection of indocyanine green (ICG) and methylene blue dye (MB) in the operating room. We utilized methylene blue dye for all subjects due to poor availability of isosulfan blue for a period of time, and to maintain consistency in the trial. Up to 1ml of MB was injected, and 0.9ml ICG (2.5 mg/ml). The ICG and MB were injected into the dermis separately, after induction of anesthesia and prior to prepping the patient.

Each lymph node basin was examined with the gamma probe and imaged with the SPY Elite (Novadaq) prior to making skin incision, with assessment of the visibility of ICG through the skin (yes or no). Once incision was made, the basin was periodically imaged with SPY, or dissection was carried out with real time lymphangiography until the sentinel node was identified. The camera of the SPY machine is positioned over the basin, with the image projected onto a monitor. Similar to laparoscopy, the surgeon can watch the image and operate at the same time. Each sentinel node was assessed for the presence of each dye. A lymph node with any one of the dyes present was considered a sentinel node, and was resected. Fluorescence and blue dye were measured as yes or no, and not quantitated. Additional data collected includes demographic data, the dose of ICG and MB given, adverse effects from any dye, the total number of sentinel nodes identified and the number of malignant sentinel nodes. Pair-wise comparisons were made between the three dyes regarding the number of detected sentinel nodes, and the number of detected metastatic nodes.

Infrared Lymphangiography as a Method of Sentinel Node Identification

The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.

Milton S. Hershey Medical Center

Associate Professor of Surgery

Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.

Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.

Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.

Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.

Indocyanine Green

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

89 subjects were enrolled, one subject retracted consent, and another was deemed ineligible after enrollment, leaving 87 evaluable participants.

Colette Pameijer, Associate Professor of Surgery

Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes

Overall Study

Breast Neoplasms

Breast Diseases

Pharmaceutical Solutions

Intervention description: Intraoperative identification of sentinel lymph node

Sentinel lymph node identification

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

Iqvia Pty Ltd

BTG International Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Ovarian Neoplasms

Vulvar Neoplasms

Anus Neoplasms

Uterine Cervical Neoplasms

Rectal Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Vulvar Diseases

Anus Diseases

Ovarian Cancer

Anal Cancer

Vulvar Cancer

Each patient receive both injections of Technetium99 (standard care) and indocyanine green.

The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.

Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)

Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.

Lymphoscintigraphy is performed to identify the sentinel node

The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.

Optonuclear probe

The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.

Quest Camera

MARCHAL FREDERIC, MD, PU-PH

This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.

The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera

Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery

Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery

The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively.

Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area.

The total number of sentinel node detected will be assess by the two techniques

False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node

Percentage of patients with allergic reactions

Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain)

The total number of sentinel node detected by fluorescence imaging

Institut de Cancérologie de Lorraine

The day of the surgery 1 ml of green indocyanine colorant will be applicated periareolar. After 5 minutes the lymph node will be detected and extracted

Application of green indocyanine colorant

Application of a periareolar injectionof TEchnetium 99 in order to detect the axillary lymph node

Sandra Lopez gordo

The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.

In the operating room 1 ml of indocyaninge grenn will be injectec periareolar . After 5 minutes the lymph node will be detected and extracted. The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed.

Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer

Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast.

With REDCap program this study will allow to participated diferents institutions (Hospitals) in Spain

Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers

assess whether there are differences in affected lymph nodes detected with indocyanine green or technetium 99 Number of possitive lymph nodes iwh indocyanine green and with technetium 99

Time in minutes from skin incision to lymp node removal.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Infrared Lymphangiography as a Method of Sentinel Node Identification	NCT02057393	Melanoma Sentinel Node	Indocyanine gre... Technetium99 Methylene blue	18 Years -	Milton S. Hershey 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.
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery	NCT02997553	Breast Carcinom... Head and Neck C... Melanoma (Skin) Squamous Cell C... Cervix Cancer Endometrium Can... Ovary Cancer Vulva Cancer Anus Cancer Rectum Cancer	Indocyanine gre... Technetium99 Optonuclear pro... Quest Camera	18 Years -	Institut de Cancérologie de Lorraine
Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer	NCT06378944	Breast Cancer	Application of ... Technetium99	18 Years - 120 Years	Omphis Foundation
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.
Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer	NCT06378944	Breast Cancer	Application of ... Technetium99	18 Years - 120 Years	Omphis Foundation
Infrared Lymphangiography as a Method of Sentinel Node Identification	NCT02057393	Melanoma Sentinel Node	Indocyanine gre... Technetium99 Methylene blue	18 Years -	Milton S. Hershey Medical Center
Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery	NCT02997553	Breast Carcinom... Head and Neck C... Melanoma (Skin) Squamous Cell C... Cervix Cancer Endometrium Can... Ovary Cancer Vulva Cancer Anus Cancer Rectum Cancer	Indocyanine gre... Technetium99 Optonuclear pro... Quest Camera	18 Years -	Institut de Cancérologie de Lorraine

Spots Global Cancer Trial Database for technetium99

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