Clinical trial NCT01262040: Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
Official title: Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Gastrointestinal Carcinoma
Pancreatic Carcinoma
Lung Cancer
Esophageal Carcinoma
Keywords: NBI
ENDOMETRIUM
FALLOPIAN TUBE
OVARY
PERITONEUM
Surgery
Lung
Pancreatic
Esophageal
thorascopic
laparoscopic
robotic
10-180
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 154
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.
timeFrame: 1 year
Secondary outcomes:
measure: Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nadeem Abu-Rustum, MD
role: PRINCIPAL_INVESTIGATOR
References: