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

NCT01939028 | Terminated Results DMC

• 2 other identifiers: CASE9813NCI-2013-01309
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I Endometrial Carcinoma; Stage II Endometrial Carcinoma; Stage III Endometrial Carcinoma; Stage IV Endometrial Carcinoma

Outcome Measures

Primary Outcomes (6)

• 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.

  Up to 4 weeks

• Number of Participants in Whom a SLN is Detected

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

  Up to 4 weeks

• Percent of Hemipelvises Identified With SLN

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

  Up to 4 weeks

• 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

  Up to 4 weeks

• 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

  Up to 4 weeks

• 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.

  Up to 4 weeks

Secondary Outcomes (2)

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

  Up to 4 weeks

• Total Operating Room Time in Minutes

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

Study Arms (1)

Diagnostic (SLN mapping, biopsy, surgery)

EXPERIMENTAL

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.

Procedure: lymph node mapping; Procedure: sentinel lymph node biopsy; Drug: isosulfan blue; Drug: indocyanine green solution; Procedure: therapeutic conventional surgery; Procedure: lymphadenectomy

Interventions

lymph node mapping PROCEDURE

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

Diagnostic (SLN mapping, biopsy, surgery)

sentinel lymph node biopsy PROCEDURE

Undergo SLN biopsy

Also known as: sentinel node biopsy

Diagnostic (SLN mapping, biopsy, surgery)

isosulfan blue DRUG

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

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

Diagnostic (SLN mapping, biopsy, surgery)

indocyanine green solution DRUG

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

Also known as: IC-GREEN, ICG solution

Diagnostic (SLN mapping, biopsy, surgery)

therapeutic conventional surgery PROCEDURE

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

Diagnostic (SLN mapping, biopsy, surgery)

lymphadenectomy PROCEDURE

Undergo para-aortic lymphadenectomy

Diagnostic (SLN mapping, biopsy, surgery)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Sentinel Lymph Node Biopsy; iso-sulfan blue; Indocyanine Green; Lymph Node Excision

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Chad Michener
• Organization: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

michenc@ccf.org

216-444-6601

Study Officials

• Chad Michener, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: September 11, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 27, 2020
• Results First Posted: August 17, 2020

Record last verified: 2020-08

Locations

US (1)