Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2010
CompletedFirst Posted
Study publicly available on registry
December 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2018
CompletedNovember 7, 2018
November 1, 2018
7.9 years
December 15, 2010
November 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.
1 year
Secondary Outcomes (1)
Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.
1 year
Study Arms (1)
pts having a thorascopic, laparoscopic or robotic procedure
EXPERIMENTALThe 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.
Interventions
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 Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadeem Abu-Rustum, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2010
First Posted
December 17, 2010
Study Start
December 14, 2010
Primary Completion
October 29, 2018
Study Completion
October 29, 2018
Last Updated
November 7, 2018
Record last verified: 2018-11