Sentinel Node Mapping in Women With Endometrial and Cervical Cancer (SENTIREC II)
Primary Purpose
Uterine Cervical Neoplasms, Uterine Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
SLN mapping and removal of PET-positive lymph nodes
Sponsored by
About this trial
This is an interventional diagnostic trial for Uterine Cervical Neoplasms focused on measuring robotic surgery procedures, indocyanine green, sentinel lymph node mapping
Eligibility Criteria
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
Sites / Locations
- Rigshospitalet
- Herlev Hospital
- Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
High risk endometrial cancer
Cervical cancer tumor size 2-4 cm
Arm Description
Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy.
Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy.
Outcomes
Primary Outcome Measures
Sensitivity
Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes
Secondary Outcome Measures
Negative predictive value
Negative predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Specificity
Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Positive predictive value
Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Prevalence of lymph node metastasis
Prevalence of lymph node metastasis in the pelvis and paraaortic area
Incidence of lymphedema
Using patient reported outcome measures
Severity of lymphedema
Using patient reported outcome measures
Quality of life rate
Using patient reported outcome measures
Full Information
NCT ID
NCT02820506
First Posted
June 23, 2016
Last Updated
May 23, 2022
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Danish Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT02820506
Brief Title
Sentinel Node Mapping in Women With Endometrial and Cervical Cancer
Acronym
SENTIREC II
Official Title
Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Danish Cancer Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Uterine Neoplasms
Keywords
robotic surgery procedures, indocyanine green, sentinel lymph node mapping
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High risk endometrial cancer
Arm Type
Other
Arm Description
Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy.
Arm Title
Cervical cancer tumor size 2-4 cm
Arm Type
Other
Arm Description
Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy.
Intervention Type
Procedure
Intervention Name(s)
SLN mapping and removal of PET-positive lymph nodes
Intervention Description
Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Negative predictive value
Description
Negative predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Time Frame
2 years
Title
Specificity
Description
Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Time Frame
2 years
Title
Positive predictive value
Description
Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Time Frame
2 years
Title
Prevalence of lymph node metastasis
Description
Prevalence of lymph node metastasis in the pelvis and paraaortic area
Time Frame
2 years
Title
Incidence of lymphedema
Description
Using patient reported outcome measures
Time Frame
3 years
Title
Severity of lymphedema
Description
Using patient reported outcome measures
Time Frame
3 years
Title
Quality of life rate
Description
Using patient reported outcome measures
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara E Sponholtz, MD
Phone
+45 28439977
Email
sara.elisabeth.sponholtz2@rsyd.dk
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara E Sponholtz, MD
Phone
+45 28439977
Email
Sara.Elisabeth.Sponholtz@rsyd.dk
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara E Sponholtz, MD
Phone
+45 28439977
Email
Sara.Elisabeth.Sponholtz@rsyd.dk
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara E Sponholtz, MD
Phone
+45 28439977
Email
Sara.Elisabeth.Sponholtz@rsyd.dk
12. IPD Sharing Statement
Citations:
PubMed Identifier
33829991
Citation
Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.
Results Reference
derived
Learn more about this trial
Sentinel Node Mapping in Women With Endometrial and Cervical Cancer
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