Clinical trials: Sentinel Lymph Node
Breast Cancer
GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study
This post-approval study is designed to determine the performance of the FDA-approved GeneSearch™ BLN Assay when compared to the site's standard of care permanent section histological evaluation, and when compared to more…
- Trial name
- NCT00595296
- Testing
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Where
- 6 sites in United States
- Volunteers
- 461 people
- Sponsor
- Janssen Diagnostics, LLC
Breast Cancer
SentiMag® Intraoperative Comparison in Breast Cancer
The purpose of this pivotal study is to provide prospective evidence that the SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a…
- Trial name
- SentiMagIC (NCT02336737)
- Testing
- SiennaXP, Technetium Tc99m Sulfur Colloid, Isosulfan blue dye
- Where
- 6 sites in United States
- Volunteers
- 160 people
- Sponsor
- Endomagnetics Inc
Breast Neoplasms, Breast Diseases
Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
This is a study to evaluate the incidence of sampling bias during pathologic assessment of sentinel lymph nodes (SLN) when they are cut at a certain thickness (1 mm) and the tissue slices are completely analyzed by histopathology…
- Trial name
- NCT01140763
- Testing
- Sysmex's 5-blade lymph node cutter
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Sysmex America, Inc.
Cancer, Malignant Melanoma
Effect of rIL-21 on Metastases in Lymph Nodes in Melanoma Skin Cancer
The trial is conducted in Europe. This trial aims for a comparison of the pathology in lymph nodes before and after the effect of recombinant interleukin-21 in patients with stage III melanoma
- Trial name
- NCT00601861
- Testing
- recombinant interleukin-21
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Novo Nordisk A/S
Breast Cancer, Lymph Node Mapping
A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an…
- Conditions
- Breast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy
- Trial name
- FILM-B (NCT03200704)
- Testing
- IC2000 and SPY-PHI, Tc-99m radioactive colloid and Gamma Probe
- Where
- 7 sites in United States, Canada
- Volunteers
- 152 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Malignant Neoplasm of Breast
ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes
Objectives of Clinical Trial The main objective of this clinical trial is to show the efficacy of fluorescence lymphangiography with indocyanine green (ICG) for the detection of sentinel lymph nodes.
- Trial name
- NCT01395706
- Testing
- ICG Fluorescence technique
- Where
- Germany
- Volunteers
- 125 people
- Sponsor
- Pulsion Medical Systems SE
Breast Cancer
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy…
- Trial name
- MAGProm (NCT06610539)
- Where
- 2 sites in United States
- Volunteers
- 184 people
- Sponsor
- Endomagnetics Ltd.
Breast Neoplasms, Breast Diseases
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section Hematoxylin and Eosin (H\&E) and…
- Trial name
- NCT01136369
- Testing
- OSNA Breast Cancer System
- Where
- 11 sites in United States
- Volunteers
- 496 people
- Sponsor
- Sysmex America, Inc.
Breast Cancer
GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study
The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test Kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of GeneSearch™ Breast Lymph Node (BLN)…
- Trial name
- NCT00869674
- Testing
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Where
- 6 sites in China
- Volunteers
- 540 people
- Sponsor
- Johnson & Johnson Medical, China
Breast Neoplasms, Breast Diseases
Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to an extensive intraoperative frozen section protocol…
- Trial name
- NCT01368744
- Testing
- OSNA Breast Cancer System
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Sysmex America, Inc.
Prostate Cancer
Evaluation of the SENSEI® Laparoscopic Tethered Gamma Probe for 99mTc-nanocolloid Sentinel Lymph Node Biopsy in Prostate Cancer
This study is a prospective, open label, single-arm study to examine the performance and safety of the SENSEI® laparoscopic tethered gamma probe in patients undergoing 99mTc-nanocolloid SLNB for prostate cancer (PCa) during RP…
- Trial name
- LPM-012 (NCT04632251)
- Testing
- SENSEI®
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 56 people
- Sponsor
- Lightpoint Medical Limited
Gastric Cancer, Esophageal Cancer
Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
This is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of using the FerroTrace® and FerroMag Sentinel Lymph…
- Trial name
- MAGMAP (NCT05899985)
- Testing
- FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System
- Where
- 4 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Ferronova Pty Ltd
Breast Cancer, DCIS
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by…
- Conditions
- Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast
- Trial name
- NCT05900986
- Testing
- LS301-IT 0.025 mg/kg, LS301-IT 0.05 mg/kg, LS301-IT 0.075 mg/kg
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Integro Theranostics
Melanoma
MElanoma Research Lymph Node Prediction Implementation National_001
MERLIN_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.
- Trial name
- MERLIN_001 (NCT04759781)
- Where
- 9 sites in United States
- Volunteers
- 1,820 people
- Sponsor
- SkylineDx
Head and Neck Squamous Cell Carcinoma (HNSCC)
Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection…
- Trial name
- NCT00911326
- Testing
- Lymphoseek
- Where
- 13 sites in United States
- Volunteers
- 101 people
- Sponsor
- Navidea Biopharmaceuticals
Uterine Cervical Neoplasms
A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix.
- Trial name
- NCT02509585
- Testing
- Tc99m tilmanocept
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Cardinal Health 414, LLC
Sentinel Lymph Node Biopsy, Breast Cancer
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery
This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control.
- Conditions
- Sentinel Lymph Node Biopsy, Breast Cancer, Melanoma
- Trial name
- NCT05457842
- Testing
- pudexacianinium chloride
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Astellas Pharma Inc
Melanoma, Head and Neck Cancer
Evaluation of Intraoperative Usage of Sentinella in Detecting Sentinel Lymph Nodes
The aim of this study is to investigate whether the Sentinella camera improves intraoperative detection and removal of sentinel lymph nodes (SLNs) when used in conjunction with standard detection methods.
- Conditions
- Melanoma, Head and Neck Cancer, Breast Cancer
- Trial name
- NCT02416336
- Testing
- Sentinella Intraoperative imaging protocol
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Oncovision Inc
Breast Cancer
GeneSearch Breast Lymph Node (BLN) Assay Timing Study
This study is designed to collect data about the amount of time required to use the assay in clinical-use conditions.
- Trial name
- NCT00595023
- Testing
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Where
- 6 sites in United States
- Volunteers
- 233 people
- Sponsor
- Janssen Diagnostics, LLC
Breast Cancer
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
- Trial name
- NCT00551278
- Testing
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Janssen Diagnostics, LLC