Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
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|ClinicalTrials.gov Identifier: NCT01262040|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2010
Last Update Posted : May 5, 2017
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 or disease||Intervention/treatment||Phase|
|Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Peritoneal Cancer Gastrointestinal Carcinoma Pancreatic Carcinoma Lung Cancer Esophageal Carcinoma||Other: Narrow Band Imaging (NBI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive|
|Actual Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
- Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery. [ Time Frame: 1 year ]
- Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262040
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Nadeem Abu-Rustum, MD||Memorial Sloan Kettering Cancer Center|