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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01262040
First received: December 15, 2010
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Gastrointestinal Carcinoma
Pancreatic Carcinoma
Lung Cancer
Esophageal Carcinoma
Other: Narrow Band Imaging (NBI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262040

Contacts
Contact: Nadeem Abu-Rustum, MD 212-639-7051
Contact: Yukio Sonoda, MD 212-639-6450

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nadeem Abu-Rustum, MD    212-639-7051      
Contact: Yukio Sonoda, MD    212-639-6450      
Principal Investigator: Nadeem Abu-Rustum         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Nadeem Abu-Rustum, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01262040     History of Changes
Other Study ID Numbers: 10-180
Study First Received: December 15, 2010
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
NBI
ENDOMETRIUM
FALLOPIAN TUBE
OVARY
PERITONEUM
Surgery
Lung
Pancreatic
Esophageal
thorascopic
laparoscopic
robotic
10-180

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Fallopian Tube Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Pancreatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014