search
Back to results

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

Primary Purpose

Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrow Band Imaging (NBI)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Cancer focused on measuring NBI, ENDOMETRIUM, FALLOPIAN TUBE, OVARY, PERITONEUM, Surgery, Lung, Pancreatic, Esophageal, thorascopic, laparoscopic, robotic, 10-180

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

  • None

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pts having a thorascopic, laparoscopic or robotic procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2010
Last Updated
November 6, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01262040
Brief Title
Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
Official Title
Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 14, 2010 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Gastrointestinal Carcinoma, Pancreatic Carcinoma, Lung Cancer, Esophageal Carcinoma
Keywords
NBI, ENDOMETRIUM, FALLOPIAN TUBE, OVARY, PERITONEUM, Surgery, Lung, Pancreatic, Esophageal, thorascopic, laparoscopic, robotic, 10-180

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pts having a thorascopic, laparoscopic or robotic procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Narrow Band Imaging (NBI)
Intervention Description
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 Measure Information:
Title
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadeem Abu-Rustum, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs