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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262040
• Other study ID #: 10-180
• Status: Completed
• Phase: N/A
• Start date: December 14, 2010
• Est. completion date: October 29, 2018

Study information

• Verified date: November 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Cancer
• Endometrial Neoplasms
• Esophageal Carcinoma
• Esophageal Neoplasms
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Gastrointestinal Carcinoma
• Lung Cancer
• Ovarian Cancer
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Peritoneal Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.		1 year
Secondary	Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.		1 year

External Links

•   Memorial Sloan Kettering Cancer Center