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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01262040
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE December 15, 2010
First Posted Date  ICMJE December 17, 2010
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE December 14, 2010
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
Determine what percentage of patients have surface metastasis identified with Narrow Band Imaging (NBI) that were not seen on white light imaging. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging. [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
Determine whether NBI identifies patients with metastatic disease who otherwise would have been considered to have low stage disease based on white light assessment alone. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
Official Title  ICMJE Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Gastrointestinal Carcinoma
  • Pancreatic Carcinoma
  • Lung Cancer
  • Esophageal Carcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE 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 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: Other: Narrow Band Imaging (NBI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2015)
154
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2010)
410
Actual Study Completion Date  ICMJE October 29, 2018
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262040
Other Study ID Numbers  ICMJE 10-180
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadeem Abu-Rustum, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP