NCT02820506

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 27, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

5.9 years

First QC Date

June 23, 2016

Last Update Submit

February 6, 2024

Conditions

Uterine Cervical NeoplasmsUterine Neoplasms

Keywords

robotic surgery proceduresindocyanine greensentinel lymph node mapping

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    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

    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 Outcomes (6)

  • Specificity

    2 years

  • Positive predictive value

    2 years

  • Prevalence of lymph node metastasis

    2 years

  • Incidence of lymphedema

    3 years

  • Severity of lymphedema

    3 years

  • +1 more secondary outcomes

Study Arms (2)

High risk endometrial cancer

OTHER

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

Cervical cancer tumor size 2-4 cm

OTHER

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

Interventions

SLN mapping and removal of PET-positive lymph nodesPROCEDURE

Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes

Cervical cancer tumor size 2-4 cmHigh risk endometrial cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 33829991DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Pernille T Jensen, Professor

    Aarhus University Hospital and Aarhus University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Endometrial cancer, Diagnostic; Assessing the safety of the SLN mapping algorithm. Inclusion is defined by a power calculation: Assuming the true incidence of metastasis is 20% and the sensitivity of the SLN mapping algorithm is 96%. To obtain the conclusion that NPV is larger than 94% using a 95% two-sided exact Clopper-Pearson confidence interval, then 150 women with sentinel lymph node mapping, a FDG/PET-CT and Pelvic- and paraaortic lymph node dissection are needed. Cervical cancer: Study is diagnostic and primarily explorative.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 23, 2016

First Posted

July 1, 2016

Study Start

February 27, 2017

Primary Completion

January 31, 2023

Study Completion

January 31, 2026

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

DK(4)