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

Not Applicable

Completed

• Conditions: Esophageal Carcinoma; Peritoneal Cancer; Gastrointestinal Carcinoma; Lung Cancer; Fallopian Tube Cancer; Ovarian Cancer; Pancreatic Carcinoma; Endometrial Cancer
• Interventions: Other: Narrow Band Imaging (NBI)

• Registration Number: NCT01262040
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-14
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• 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)

Patients must meet all of the following criteria:

• 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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pts having a thorascopic, laparoscopic or robotic procedure	Narrow Band Imaging (NBI)	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 quadrant inspection of the peritoneal cavity under NBI will be done, this is the only experimental component of the design. White light imaging will always be done first, followed by NBI. For those patients scheduled for thorascopic procedures: The procedure will begin with sampling of pleural effusions when clinically indicated. Then there will be two assessments of the pleural surfaces. First, an inspection of the pleural cavity under white light, this is the standard of care assessment. Then, a repeat inspection under NBI, this is the only experimental component of the design. White light imaging will always be done first, followed by NBI.

Primary Outcome Measures

Name	Time	Method
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.	1 year

Secondary Outcome Measures

Name	Time	Method
Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.	1 year

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States