Sentinel Node Mapping in Women With Endometrial and Cervical Cancer (SENTIREC II)

February 6, 2024 updated by: Sara Sponholtz, University of Southern Denmark

Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer

The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Study IIA: Patients with cervical cancer, FIGO IB1, tumor size 2-4 cm
  • Study IIB: Patients with high risk endometrial cancer, presumed FIGO I, type 1 histology grade 3 Endometrioid adenocarcinoma or type 2 histology (serous-, clearcel-, carcinosarcoma or undifferentiated adenocarcinoma.

Exclusion Criteria:

  • Prior PL
  • Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
  • Women included in other studies affecting outcome-measures of the present study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cervical cancer tumor size 2-4 cm
Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy.
Procedure: SLN mapping and removal of PET-positive lymph nodes
Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes
Other: High risk endometrial cancer
Patients will receive sentinel node mapping, removal of PET-positive lymph nodes and finally conventional pelvic and paraaortic lymphadenectomy.
Procedure: SLN mapping and removal of PET-positive lymph nodes
Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 2 years
Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes
2 years
Negative predictive value
Time Frame: 2 years
Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: 2 years
Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
2 years
Positive predictive value
Time Frame: 2 years
Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
2 years
Prevalence of lymph node metastasis
Time Frame: 2 years
Prevalence of lymph node metastasis in the pelvis and paraaortic area
2 years
Incidence of lymphedema
Time Frame: 3 years
Using patient reported outcome measures
3 years
Severity of lymphedema
Time Frame: 3 years
Using patient reported outcome measures
3 years
Quality of life rate
Time Frame: 3 years
Using patient reported outcome measures
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
Danish Cancer Society

Investigators

  • Principal Investigator: Pernille T Jensen, Professor, Aarhus University Hospital and Aarhus University, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2017

Primary Completion (Actual)

January 31, 2023

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimated)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDUSF12015163 1 (198)1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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