Endometrial CancerNCT01562106
Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery
A study testing Fluorescence-guided sentinel lymph node detection in people with Endometrial Cancer, run by Swedish Medical Center at 3 sites in United States.
Trial summary
The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Fluorescence-guided sentinel lymph node detection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to Aug 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven endometrial carcinoma
- Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care
- Must be 18 years of age and older
- Must be able to comply with all the study procedures
Who cannot join
- Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin > 1.5 times normal, and/or SGOT > 2 times normal
- Uremia, serum creatinine > 2.0 mg/dl
- Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes
- Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage
- Pregnant
- Currently participating in a drug, biologic and/or device treatment study
- Any medical condition that would normally prevent someone from receiving general anesthesia or undergoing standard surgical procedures
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Swedish Medical Center Issaquah Campus
Issaquah, Washington, 98027
Pacific Gynecology Specialists
Seattle, Washington, 98104
Swedish Medical Center
Seattle, Washington, 98104
About this study
Official title: A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.
Read the detailed description
In many cancer types, such as breast cancer and melanoma, sentinel node assessment has become the standard of care surgical treatment. Sentinel nodes are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. Removal of a sentinel node for examination accurately predicts whether the cancer has spread to other nodes further along in the nodal chain. Fluorescence imaging with ICG dye (Indocyanine Green) has been used to detect lymph nodes in patients with gastric, colorectal and breast cancer. To date, the use of this technique in endometrial cancer has not been reported.
- Conditions
- Endometrial Cancer
- Being tested
- Fluorescence-guided sentinel lymph node detection
- Keywords
- Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence-guided sentinel lymph node detectionProcedure or surgery
During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.
| Study group | Role | What they receive |
|---|---|---|
| ICG Dye | Experimental | Fluorescence-guided sentinel lymph node detection Receives: Procedure: Fluorescence-guided sentinel lymph node detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
Measured: Average expected time of 12 weeks
Secondary outcomes (1)
Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
In cancer, "upstaging" is changing the stage used to describe a patient's cancer from a lower stage (less extensive) to a higher stage (more extensive). The sentinel lymph nodes removed during the flourescence guided surgery will be examined microscopically to determine how often upstaging occurred.
Measured: Average expected time of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2015
- Study completionAug 2016
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.
- 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Paley, MD, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562106
- Sponsor's protocol ID
- IR 5197
- Status last verified
- Nov 2016
- First submitted
- 21 Mar 2012
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation of the Use of Fluorescence Imaging on the da Vinci Surgical System for Ultrastaging of Endometrial Cancer by Sentinel Node Assessment
- ClinicalTrials.gov ID
- NCT01562106
- Acronym / sponsor ID
- IR 5197
- Conditions
- Endometrial Cancer
- Keywords
- Cancer of Endometrium, Cancer of the Endometrium, Carcinoma of Endometrium, Endometrial Carcinoma, Endometrium Cancer, Neoplasms, Endometrial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 23 Mar 2012 (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 main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.
Detailed description
In many cancer types, such as breast cancer and melanoma, sentinel node assessment has become the standard of care surgical treatment. Sentinel nodes are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. Removal of a sentinel node for examination accurately predicts whether the cancer has spread to other nodes further along in the nodal chain. Fluorescence imaging with ICG dye (Indocyanine Green) has been used to detect lymph nodes in patients with gastric, colorectal and breast cancer. To date, the use of this technique in endometrial cancer has not been reported.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG Dye | Experimental | Procedure: Fluorescence-guided sentinel lymph node detectionFluorescence-guided sentinel lymph node detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy proven endometrial carcinoma
- Must have planned to undergo standard endometrial cancer staging surgery as part of their routine clinical care
- Must be 18 years of age and older
- Must be able to comply with all the study procedures
Key exclusion criteria (7 listed)
- Significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, with total bilirubin > 1.5 times normal, and/or SGOT > 2 times normal
- Uremia, serum creatinine > 2.0 mg/dl
- Previous history of adverse reaction or allergy to ICG dye, iodine, shellfish, or iodine dyes
- Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage
- Pregnant
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 |
|---|---|---|
| Fluorescence-guided sentinel lymph node detectionDuring standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis. | Procedure or surgery | ICG Dye |
Primary outcome
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer.
Time frame: Average expected time of 12 weeks
1 secondary outcome
Determine the rate of upstaging using fluorescence-guided sentinel lymph node assessment by microscopic evaluation.
Time frame: Average expected time of 12 weeks
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 18 Nov 2016.
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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.
Pamela Paley, MD principal investigator
Swedish Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence-guided sentinel lymph node detection in people with Endometrial Cancer, run by Swedish Medical Center at 3 sites 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 4 inclusion and 7 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Evaluating detection rate and accuracy of fluorescence-guided sentinel lymph node detection in endometrial cancer. (time frame: Average expected time of 12 weeks). 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 18 Nov 2016.