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Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

Primary Purpose

Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

lymph node mapping

sentinel lymph node biopsy

isosulfan blue

indocyanine green solution

therapeutic conventional surgery

lymphadenectomy

About this trial

This is an interventional diagnostic trial for Stage I Endometrial Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer
Women should have received no prior therapy for their disease
Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer
Women must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Women who are receiving any other investigational agents
Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study
Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides
Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix
Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)
Women with a history of a prior malignancy
Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate

Sites / Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (SLN mapping, biopsy, surgery)

Arm Description

Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.

Outcomes

Primary Outcome Measures

Sensitivity of Sentential Lymph Node (SLN) Biopsy

Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node.

Number of Participants in Whom a SLN is Detected

Detection Rate as defined by number of participants in whom a SLN is detected

Percent of Hemipelvises Identified With SLN

Detection rate, as defined by percent of hemipelvises identified with SLN

Number of Participants With Sentinel Nodes Per Side of Pelvis

Detection rate, as defined as number of participants with a sentinel node found per side of pelvis

False Negative Rate as Defined as Proportion of Participants With False Negative Detection

False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node

Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)

The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation.

Secondary Outcome Measures

Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution

Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation.

Total Operating Room Time in Minutes

Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time.

Full Information

NCT ID

NCT01939028

First Posted

July 10, 2013

Last Updated

August 26, 2020

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01939028

Brief Title

Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

Official Title

Sentinel Lymph Node Mapping for Endometrial Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

Slow Accrual

Study Start Date

July 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients. SECONDARY OBJECTIVES: I. To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy. II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures. OUTLINE: Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. After completion of study treatment, patients are followed up at 2-4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (SLN mapping, biopsy, surgery)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

lymph node mapping

Intervention Description

Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution

Intervention Type

Procedure

Intervention Name(s)

sentinel lymph node biopsy

Other Intervention Name(s)

sentinel node biopsy

Intervention Description

Undergo SLN biopsy

Intervention Type

Drug

Intervention Name(s)

isosulfan blue

Other Intervention Name(s)

Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide

Intervention Description

Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution

Intervention Type

Drug

Intervention Name(s)

indocyanine green solution

Other Intervention Name(s)

IC-GREEN, ICG solution

Intervention Description

Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Description

Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy

Intervention Type

Procedure

Intervention Name(s)

lymphadenectomy

Intervention Description

Undergo para-aortic lymphadenectomy

Primary Outcome Measure Information:

Title

Sensitivity of Sentential Lymph Node (SLN) Biopsy

Description

Time Frame

Up to 4 weeks

Title

Number of Participants in Whom a SLN is Detected

Description

Detection Rate as defined by number of participants in whom a SLN is detected

Time Frame

Up to 4 weeks

Title

Percent of Hemipelvises Identified With SLN

Description

Detection rate, as defined by percent of hemipelvises identified with SLN

Time Frame

Up to 4 weeks

Title

Number of Participants With Sentinel Nodes Per Side of Pelvis

Description

Detection rate, as defined as number of participants with a sentinel node found per side of pelvis

Time Frame

Up to 4 weeks

Title

False Negative Rate as Defined as Proportion of Participants With False Negative Detection

Description

False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node

Time Frame

Up to 4 weeks

Title

Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)

Description

Time Frame

Up to 4 weeks

Secondary Outcome Measure Information:

Title

Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution

Description

Time Frame

Up to 4 weeks

Title

Total Operating Room Time in Minutes

Description

Time Frame

From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer Women should have received no prior therapy for their disease Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer Women must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Women who are receiving any other investigational agents Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease) Women with a history of a prior malignancy Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chad Michener, MD

Organizational Affiliation

Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

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