Endometrial CancerNCT01818739
Lymph Node Mapping in Patients With Endometrial Cancer
A study testing sentinel lymph node detection, indocyanine green solution and isosulfan blue in people with Endometrial Cancer, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- sentinel lymph node detection, indocyanine green solution and isosulfan blue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be willing and able to provide informed consent
- The patient is willing and able to comply with the study protocol
- The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy
- The patient agrees to follow-up examinations out to 5-years post-treatment
Who cannot join
- The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy
- The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB)
- The patient has hepatic dysfunction confirmed by bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06520
About this study
Official title: Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue and Indocyanine Green Dyes With Fluorescence Imaging
This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis.
SECONDARY OBJECTIVE:
II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H\&E) results.
OUTLINE:
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.
- Conditions
- Endometrial Cancer
- Being tested
- sentinel lymph node detection, indocyanine green solution, isosulfan blue, sentinel lymph node biopsy
- Keywords
- Endometrial Cancer, Robotic-Assisted Staging
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel lymph node detectionProcedure or surgery
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
indocyanine green solutionDrug
Also called IC-GREEN, ICG solution
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
isosulfan blueDrug
Also called Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
sentinel lymph node biopsyProcedure or surgery
Also called sentinel node biopsy
Undergo sentinel lymph node biopsy
| Study group | Role | What they receive |
|---|---|---|
| sentinel lymph node detection | Experimental | Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy. Receives: Procedure: sentinel lymph node detection; Drug: indocyanine green solution; Drug: isosulfan blue; Procedure: sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease
NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated.
Measured: average of 1-14 days after the procedure when final pathologic evaluation has been completed
Secondary outcomes (1)
Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining
The percentage of metastatic cases analyzed by H\&E will be compared to those of H\&E-plus- IHC/ultrastaging using a "z-test".
Measured: average of 1-14 days after the procedure when final pathologic evalulation has been completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completion16 Nov 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Floor Backes, Ohio State University Comprehensive Cancer Center
- Investigators
- Floor Backes, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818739
- Sponsor's protocol ID
- OSU-12114
- Other IDs
- NCI-2013-00530
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2013
- Last updated
- 22 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Publications
Backes FJ, Cohen D, Salani R, Cohn DE, O'Malley DM, Fanning E, Suarez AA, Fowler JM. Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging (NCT01818739). Gynecol Oncol. 2019 Jun;153(3):496-499. doi: 10.1016/j.ygyno.2019.03.252. Epub 2019 Apr 4.
PubMed 31230614
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue and Indocyanine Green Dyes With Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT01818739
- Acronym / sponsor ID
- OSU-12114
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Robotic-Assisted Staging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.
Detailed description
PRIMARY OBJECTIVE:
- To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis.
SECONDARY OBJECTIVE:
II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H\&E) results.
OUTLINE:
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sentinel lymph node detection | Experimental | Procedure: sentinel lymph node detection, Drug: indocyanine green solution, Drug: isosulfan blue, Procedure: sentinel lymph node biopsyPatients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be willing and able to provide informed consent
- The patient is willing and able to comply with the study protocol
- The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy
- The patient agrees to follow-up examinations out to 5-years post-treatment
Key exclusion criteria (3 listed)
- The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy
- The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB)
- The patient has hepatic dysfunction confirmed by bilirubin > 2 x normal (based on reference values from the laboratory used by the patient)
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 |
|---|---|---|
| sentinel lymph node detectionUndergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue | Procedure or surgery | sentinel lymph node detection |
| indocyanine green solutionAlso: IC-GREEN, ICG solutionUndergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue | Drug | sentinel lymph node detection |
| isosulfan blueAlso: Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxideUndergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue | Drug | sentinel lymph node detection |
| sentinel lymph node biopsyAlso: sentinel node biopsyUndergo sentinel lymph node biopsy | Procedure or surgery | sentinel lymph node detection |
Primary outcome
Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease
Time frame: average of 1-14 days after the procedure when final pathologic evaluation has been completed
NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated.
1 secondary outcome
Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining
Time frame: average of 1-14 days after the procedure when final pathologic evalulation has been completed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31230614Backes FJ, Cohen D, Salani R, Cohn DE, O'Malley DM, Fanning E, Suarez AA, Fowler JM. Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging (NCT01818739). Gynecol Oncol. 2019 Jun;153(3):496-499. doi: 10.1016/j.ygyno.2019.03.252. Epub 2019 Apr 4.
- The JameslineLink 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.
Floor Backes, MD principal investigator
Ohio State University Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sentinel lymph node detection, indocyanine green solution and isosulfan blue in people with Endometrial Cancer, run by Ohio State University Comprehensive Cancer Center at 2 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 3 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease (time frame: average of 1-14 days after the procedure when final pathologic evaluation has been completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01818739, which also lists 1 linked publication.
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 22 Mar 2023.