Narrow Band Imaging (NBI): A Novel Imaging Modality In Minimally Invasive

Study Overview

Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive

The purpose of this study is to determine whether narrowband imaging (NBI) makes it easier for a surgeon to see cancer. NBI is a kind of light. Normally, white light is used during surgery. White light uses many wavelengths of light. NBI only uses two wavelengths which highlight the blood vessels. This makes it easier for the surgeon to see blood vessels. Tumors often have more blood vessels than normal tissue. As a result, NBI may make it easier for the surgeon to see small tumors. In this study the surgeon will look with both normal white light and NBI. This way a comparison can be made to determine which is superior. Improved identification of tumors allows doctors and patients to make informed decisions about whether treatment is needed after surgery. It also provides additional information to determine which treatments may be best.

N/A

Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Gastrointestinal Carcinoma
Pancreatic Carcinoma
Lung Cancer
Esophageal Carcinoma

OTHER: Narrow Band Imaging (NBI)

10-180

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-12-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-11-06
First Submitted that Met QC Criteria 2010-12-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-11-07
First Posted (ACTUAL) 2010-12-17	Results First Posted N/A	Last Verified 2018-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: pts having a thorascopic, laparoscopic or robotic procedure The procedure will begin with washings (peritoneal) and two assessments of the extent of peritoneal disease. First, a four quadrant inspection of the peritoneal cavity under white light, this is the standard of care assessment. Then, a repeat four quadran	OTHER: Narrow Band Imaging (NBI) The intervention is visual assessment of the peritoneal or pleural surface with NBI followed by biopsy and photographic documentation of any abnormal lesions. Photograph or video of abnormality(ies) under white light and NBI.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: pts having a thorascopic, laparoscopic or robotic procedure

The procedure will begin with washings (peritoneal) and two assessments of the extent of peritoneal disease. First, a four quadrant inspection of the peritoneal cavity under white light, this is the standard of care assessment. Then, a repeat four quadran

OTHER: Narrow Band Imaging (NBI)

The intervention is visual assessment of the peritoneal or pleural surface with NBI followed by biopsy and photographic documentation of any abnormal lesions. Photograph or video of abnormality(ies) under white light and NBI.

Primary Outcome Measures	Measure Description	Time Frame
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.		1 year

Secondary Outcome Measures	Measure Description	Time Frame
Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

Patients must meet one (or more) of the following criteria:
Preoperative diagnosis of ovarian, fallopian tube, or primary peritoneal carcinoma (all stage, grade and histology)
Preoperative diagnosis of grade III endometrial carcinoma (all stage, all histology)
Preoperative diagnosis of uterine serous carcinoma (all stage, all grade)
Preoperative diagnosis of clear cell endometrial carcinoma (all stage, all grade)
Preoperative diagnosis of endometrial carcinosarcoma (all stage, all grade)
Gastrointestinal carcinoma (all histology, stage and grade)
Pancreatic carcinoma (all histology, stage and grade)
Lung cancer (all histology, stage and grade)
Esophageal carcinoma (all histology, stage and grade)
Suspected or pathologically confirmed metastatic disease to the lung (all disease primaries)
Suspected or pathologically confirmed malignant pleural effusion (all disease primaries)

Planned thorascopic robotic or laparoscopic surgical approach
>18 years old
Not pregnant
Able to give consent Participation in other research protocols does not exclude a patient from participation in this study.

None

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Nadeem Abu-Rustum, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record