Endometrial CancerNCT01262040
Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
A study testing Narrow Band Imaging (NBI) in people with Endometrial Cancer and Fallopian Tube Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer
- What is being tested?
- Narrow Band Imaging (NBI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2010to 29 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
Read more
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.
- Conditions
- Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Gastrointestinal Carcinoma, Pancreatic Carcinoma
- Being tested
- Narrow Band Imaging (NBI)
- Keywords
- NBI, ENDOMETRIUM, FALLOPIAN TUBE, OVARY, PERITONEUM, Surgery, Lung, Pancreatic, Esophageal, thorascopic, laparoscopic, robotic, 10-180
- Medical subject headings
- Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow Band Imaging (NBI)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| pts having a thorascopic, laparoscopic or robotic procedure | Experimental | 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. Receives: Other: Narrow Band Imaging (NBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.
Measured: 1 year
Secondary outcomes (1)
Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study start14 Dec 2010
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadeem Abu-Rustum, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262040
- Sponsor's protocol ID
- 10-180
- Status last verified
- Nov 2018
- First submitted
- 15 Dec 2010
- Last updated
- 7 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive
- ClinicalTrials.gov ID
- NCT01262040
- Acronym / sponsor ID
- 10-180
- Conditions
- Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Gastrointestinal Carcinoma, Pancreatic Carcinoma
- Keywords
- NBI, ENDOMETRIUM, FALLOPIAN TUBE, OVARY, PERITONEUM, Surgery, Lung, Pancreatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 14 Dec 2010 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pts having a thorascopic, laparoscopic or robotic procedure | Experimental | Other: Narrow Band Imaging (NBI)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | pts having a thorascopic, laparoscopic or robotic procedure |
Primary outcome
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery.
Time frame: 1 year
1 secondary outcome
Determine what percentage of patients have surface metastasis identified with NBI that were not seen on white light imaging.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadeem Abu-Rustum, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow Band Imaging (NBI) in people with Endometrial Cancer and Fallopian Tube Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of Narrow Band Imaging (NBI) at the time of thorascopic, laparoscopic or robotic surgery. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.