Status:
UNKNOWN
Sentinel Node in Endometrial Cancer
Lead Sponsor:
Judit Pich Martínez
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Phase II, open-label, randomized pilot study. Patients will be randomized (1:1) to receive for sentinel node screening: 1. Radiotracer (RT) via cervical administration and TUMIR 2. Combination of RT...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histological diagnosis of endometrial cancer with criteria of high risk according to the following criteria: - unfavorable histology according to FIGO (adenocarcinoma serous, clear cell, or carcinosarcoma) - nuclear grade 3 - suspected myometrial invasion\> 50% by resonance magnetic (MR) or transvaginal ultrasound
- Women of childbearing age should have a transvaginal ultrasound who rule out pregnancy and must commit to using methods highly effective contraceptives (vasectomized couple and sexual abstinence) until the hysterectomy is performed.
- Patient who gives written informed consent.
Exclusion
- Pregnancy or lactation.
- Suspected lymph node or distant metastatic disease in the preoperative study.
- History of previous surgery or radiotherapy in the pelvic and paraortic lymphatic drainage areas or nodal involvement of any other etiology.
- Body mass index (BMI) greater than 45 Kg / m2.
- Patients who, in the researcher's opinion, are not suitable for participate, regardless of reason, including medical or clinical, or participants potentially at risk of not comply with the study procedures.
- Known hypersensitivity to some of the active substances or excipients from RT or ICG (including previous history of hypersensitivity to products containing human albumin).
- Hypersensitivity to sodium iodide.
- Patients allergic to iodine.
- Patients with clinical hyperthyroidism, thyroid adenomas autonomic and diffuse focal and autonomic disturbances of the gland thyroid.
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04492995
Start Date
October 5 2020
End Date
September 30 2023
Last Update
September 18 2023
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Spain, 08036