Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Uterine Cervical Neoplasms Uterine Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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High risk endometrial cancer

Patients will receive sentinel node mapping, removal of PET-positive lymph nodes and finally conventional pelvic and paraaortic lymphadenectomy.

Group Type OTHER

SLN mapping and removal of PET-positive lymph nodes

Intervention Type PROCEDURE

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

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.

Group Type OTHER

SLN mapping and removal of PET-positive lymph nodes

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No