Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion

A low anterior resection will be performed according to the surgeon's standard practice

PINPOINT

SPY Elite

Michael J Stamos, MD

Steven Wexner, MD

This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure

Rate of postoperative abscess requiring surgical management.

Novadaq Technologies ULC, now a part of Stryker

Adverse events were monitored/assessed for all randomized subjects. 8 subjects were withdrawn after randomized and not treated either by SPY or STANDARD treatments.

PINPOINT or SPY Elite

STANDARD

Not treated by either perfusion (PINPOINT/SPY Elite) or standard treatment.

Not Treated

Total

Mean

Age, Customized

Sex: Female, Male

Race/Ethnicity

Race/Ethnicity, Customized

Height

Weight

Smoking Status

Alcohol Consumption

The Model for End-Stage Liver Disease (MELD) consists of serum bilirubin, creatinine levels, International Normalized Ratio (INR) for prothrombin time, and Serum Sodium levels. Subjects with hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score \>12 were excluded from the study. The MELD score can range from 6 to 40 with higher numbers indicating more severe disease.

MELD Score (Model for End-Stage Liver Disease)

Long-Course Neoadjuvant Therapy

Pre-Operative Diagnosis

The interpretation of the efficacy results is limited due to the fact that the study was stopped early, which may have adversely affected the statistical power of some tests.

Alicia Wilton

Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.

Anastomotic Leak Rate

Rate of SPY Visualization and Tissue Perfusion

Incidence of Post-Operative Abscess Requiring Surgical Management

Overall Study

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	Link
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection	NCT02205307	Rectal Cancer Rectosigmoid Ca...	PINPOINT SPY Elite	18 Years -	Novadaq Technologies ULC, now a part of Stryker
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 spy elite

Every month we try and update this database with for spy elite 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 spy elite

Every month we try and update this database with for spy elite 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 spy elite 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.