Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
This study is currently recruiting participants.
Verified February 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01262040
First received: December 15, 2010
Last updated: February 12, 2013
Last verified: February 2013
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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:
MedlinePlus related topics:
Benign Tumors
Cancer
Esophageal Cancer
Esophagus Disorders
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
U.S. FDA Resources
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 2013 |
| Estimated Primary Completion Date: | December 2013 (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
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: | February 12, 2013 |
| 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 Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Lung Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Rectal Neoplasms Duodenal Neoplasms Bile Duct Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Head and Neck Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
ClinicalTrials.gov processed this record on May 19, 2013