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Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease

Primary Purpose

Sentinel Lymph Node, Endometrial Cancer, Lymphedema

Status

Not yet recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Injection of tracer ( ICG) and detection of sentinel lymph nodes

About this trial

This is an interventional diagnostic trial for Sentinel Lymph Node

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women of age 18 years and older at the time of informed consent.
Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery
A uterine size allowing minimally invasive surgery
Women must be able to understand and sign an informed consent in Swedish language.
Absence of any exclusion criteria

Exclusion Criteria:

Non consenting patients
Ongoing pregnancy
Inability to understand written and/or oral study information
WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more)
Previous lower limb lymphedema ( only for the lymphedema part of study)
Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography.
Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
Allergy to Iodine
Patients with a known liver disease
Patients with a bleeding disorder or mandatory antithrombotic treatment.

Sites / Locations

Department of Gynecology and Obstetrics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SLN only

Arm Description

Pelvic SLN's defined by ICG injected cervically

Outcomes

Primary Outcome Measures

Detection rate of pelvic metastatic disease in endometrial cancer

The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases

Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes

Exact measurements of time allocated for the SLN procedure as such.

Secondary Outcome Measures

Incidence of lymphedema after removal of sentinel lymph nodes

Objective measurement lymphedema defined by of leg volume before and after surgery

intraoperative adverse events associated with the study intervention

Detailed registration of adverse events associated with the SLN procedure as such

Full Information

NCT ID

NCT03838055

First Posted

December 21, 2018

Last Updated

February 8, 2019

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT03838055

Brief Title

Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease

Official Title

Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 2019 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.

Detailed Description

Consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy. A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant treatment. The detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data. Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL questionnaire.

6. Conditions and Keywords

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

Sentinel Lymph Node, Endometrial Cancer, Lymphedema

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective cohort study

Masking

None (Open Label)

Allocation

N/A

Enrollment

362 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SLN only

Arm Type

Experimental

Arm Description

Pelvic SLN's defined by ICG injected cervically

Intervention Type

Procedure

Intervention Name(s)

Injection of tracer ( ICG) and detection of sentinel lymph nodes

Intervention Description

Pelvic SLN's defined by ICG injected cervically

Primary Outcome Measure Information:

Title

Detection rate of pelvic metastatic disease in endometrial cancer

Description

The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases

Time Frame

3 years from start inclusion with an interim analysis after 150 patients

Title

Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes

Description

Exact measurements of time allocated for the SLN procedure as such.

Time Frame

3 years from start inclusion

Secondary Outcome Measure Information:

Title

Incidence of lymphedema after removal of sentinel lymph nodes

Description

Objective measurement lymphedema defined by of leg volume before and after surgery

Time Frame

4 years including at least one year follow up

Title

intraoperative adverse events associated with the study intervention

Description

Detailed registration of adverse events associated with the SLN procedure as such

Time Frame

3 years from start inclusion or after 150 patients if study stopped at interim analysis

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women of age 18 years and older at the time of informed consent. Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery A uterine size allowing minimally invasive surgery Women must be able to understand and sign an informed consent in Swedish language. Absence of any exclusion criteria Exclusion Criteria: Non consenting patients Ongoing pregnancy Inability to understand written and/or oral study information WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more) Previous lower limb lymphedema ( only for the lymphedema part of study) Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography. Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion. Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion Allergy to Iodine Patients with a known liver disease Patients with a bleeding disorder or mandatory antithrombotic treatment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jan Persson, Ass prof

Phone

0046733522080

jan.persson@med.lu.se

First Name & Middle Initial & Last Name or Official Title & Degree

Michele Bollino, MD

Phone

0046723059274

michele.bollino@med.lu.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Persson, Ass Prof

Organizational Affiliation

RegionSkane, department of OB&G, Skåne university hospital, Lund

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Gynecology and Obstetrics

City

Lund

ZIP/Postal Code

22185

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease

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