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

University of Southern Denmark (SDU)

Status: Active, not recruiting

Conditions: Uterine Cervical Neoplasms; Uterine Neoplasms

Treatments: Procedure: SLN mapping and removal of PET-positive lymph nodes

Study type: Interventional

Funder types: Other

Identifiers

NCT02820506

SDUSF12015163 1 (198)1

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

High risk endometrial cancer

Other group

Description:

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

Treatment:

Procedure: SLN mapping and removal of PET-positive lymph nodes

Cervical cancer tumor size 2-4 cm

Other group

Description:

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

Treatment:

Procedure: SLN mapping and removal of PET-positive lymph nodes