Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Herbal and Botanical

Technetium Tc 99m Sulfur Colloid

Radiopharmaceuticals

Cola

Lymph node mapping and sentinel lymph node biopsy. Patients undergo preoperative endoscopy with injection of technetium Tc 99m sulfur colloid around tumor followed by celiotomy and intraabdominal exploration. At 30 minutes following injection, patients undergo lymphatic mapping with a gamma probe and biopsy of the sentinel lymph node(s). Following biopsy and mapping, patients undergo resection of primary tumor.

Preoperative Endoscopy

Gamma Probe

Biopsy of Sentinel Lymph Nodes

Timothy J. Yeatman, M.D.

RATIONALE: Diagnostic procedures, such as lymph node mapping and biopsy, may improve the ability to detect the extent of colorectal cancer.

PURPOSE: Diagnostic trial to study the feasibility of lymph node mapping and sentinel lymph node biopsy in patients who have stage I, stage II, or stage III colorectal cancer.

OBJECTIVES: I. Determine the feasibility of lymphatic mapping and sentinel lymph node biopsy in patients with stage I, II, or III colorectal cancer. II. Evaluate technetium Tc 99m sulfur colloid as a mapping agent in this patient population. III. Identify patients with histologically negative nodes but have positive nodes on further detailed examination.

OUTLINE: Patients undergo preoperative endoscopy with injection of technetium Tc 99m sulfur colloid around tumor followed by celiotomy and intraabdominal exploration. At 30 minutes following injection, patients undergo lymphatic mapping with a gamma probe and biopsy of the sentinel lymph node(s). Following biopsy and mapping, patients undergo resection of primary tumor. Patients are followed postoperatively, every 4-6 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.

Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer

Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer: A Feasibility Study

Determine the feasibility of lymphatic mapping and sentinel lymph node biopsy in patients with stage I, II, or III colorectal cancer. Evaluate technetium Tc 99m sulfur colloid as a mapping agent in this patient population. Identify patients with histologically negative nodes but have positive nodes on further detailed examination.

National Cancer Institute (NCI)

H. Lee Moffitt Cancer Center and Research Institute

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Micronutrients

Anti-Infective Agents

Iodine

Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes.

Smart Goggle is a novel stereoscopic wearable multimodal intraoperative imaging and display systems entitled Integrated Imaging Goggles for assessment of SLNs. The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. The investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nM concentration). The hand-held microscopy module has a resolution of 25 micron. The prototype system has 2 complementary metal-oxide-semiconductor (CMOS) imaging sensors housed on a printed circuit board (PCB) with imaging lenses and emission filters optimized for ICG dye. The light source provides concurrent excitation centered at 780 nm and white light illumination with OD6 level cut-off. The Smart Goggles is a non-invasive imaging system that does not require contact with patients.

Smart Goggle

Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously.

Cardio-Green

Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity

SPY Elite Imaging system

Quest near-infrared (NIR) Imaging system

PDE Imaging system

Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.

Gamma probe

Blue Dyes

Stephanie A Valente, DO

Stephanie Valente, DO

This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.

Primary Objective -Positive fluorescence signal in SLNs imaged by the Smart Goggles system.

Secondary Objectives

* Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
* Comparison of lesions detected by the Smart Goggles vs. lesions detected using SPY/Quest/PDE vs. gold standard of gamma probe and blue dyes.

Exploratory Objectives

-Collection of preliminary data for a future, powered study for lymphatic mapping in breast cancer

Study Design This is an unpowered pilot study to determine the sensitivity of the new Smart Goggles device, for detection of ICG fluorescence in SLNs of breast cancers in a clinical setting. The investigators have chosen to examine ICG as the contrast agent and breast cancer as the clinical target, because this agent is FDA-approved and is regularly used for lymphatic mapping (skin cancers). The study team will be applying ICG for the same length of time as the standard-of-care procedures including radiotracers and blue dyes. The study involves a single visit, lasting \~3-4 hours total. Multiple SLN biopsies will be performed if multiple SLNs are identified.

Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions

Evaluation of an Integrated Imaging System (Smart Goggles) For In Vivo Detection of Fluorescently Labeled Lymph Nodes for Breast Cancer: A Pilot Study To Visualize Sentinel Lymph Nodes After Periareolar Injection of Indocyanine Green

Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs.

A commercial imaging system that measures fluorescence output of ICG will be used to measure the near infrared fluorescence in vivo. Measurements are painless and involve no risk to the participant. The measurements are non-contact and recorded by a computer; each measurement is painless and takes 10 seconds. The signal is calibrated against known fluorescence standards, and the relative amount of ICG in a given measurement is interpolated from the standard curve.

Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.

Confirmation of lymph node tissue within lesions per histologic tissue exam by SLN biopsy.

Fluorescence intensity will be compared for the removed lymph nodes between the Smart Goggles and the standard used fluorescent imaging technology. Intensity will be reported in Arbitrary units

·

Standard histological analyses will be performed on the biopsy specimens. Presence of absence of cancer cells in the removed lymph nodes will serve as the source of specificity.

The ICG accumulation curve generated from each device (Smart Goggles vs previously validated fluorescence imaging systems), measured on the same SLN, will be used to characterize the relative sensitivity of the Smart Goggles for ICG detection in vivo.

The ICG accumulation curve generated from each device (Smart Goggles vs previously validated fluorescence imaging systems), measured on the same SLN, will be used to characterize the relative specificity of the Smart Goggles for ICG detection in vivo.

Surgeons preference for using the Googles for ICG detection versus the current near-infrared NIR cameras

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer	NCT00005640	Colorectal Canc...	Preoperative En... Technetium Tc 9... Gamma Probe Biopsy of Senti...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer	NCT00005640	Colorectal Canc...	Preoperative En... Technetium Tc 9... Gamma Probe Biopsy of Senti...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer	NCT00005640	Colorectal Canc...	Preoperative En... Technetium Tc 9... Gamma Probe Biopsy of Senti...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions	NCT02802553	Invasive Breast...	Smart Goggle Cardio-Green SPY Elite Imagi... Quest near-infr... PDE Imaging sys... Gamma probe Blue Dyes	18 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for gamma probe

Every month we try and update this database with for gamma probe cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gamma probe

Every month we try and update this database with for gamma probe cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gamma probe cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.