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OpenTrials
Completed

NCT Number: NCT01262040

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narrow Band Imaging (NBI)

Other

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 outcomes

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

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Dec 17, 2010
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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