The Role of Pre-Surgical Tru - Cut Biopsy in the Management of Atypical Myometrial Lesions

A total of 250 patients is planned to be enrolled, accounting for an estimated 15% dropout rate. Study data will be collected and managed using REDCap (Research Electronic Data Capture) open-source platform, which allows for the secure collection of research data via a web-based interface. REDCap was developed by Vanderbilt University in Nashville, Tennessee, is used by Charles University in Prague under a standing agreement to allow the usage of REDCap for academic and research purposes. The REDCap platform environment is compliant with 21 CFR Part 11, FISMA, HIPAA, and GDPR.

Patients will be identified at each of the participating site. If a patient meets all inclusion criteria, she will be informed about the study and asked to sign an informed consent (ICF). All patients referred for TCB will have their blood count and baseline coagulation parameters checked prior to performing the biopsy to eliminate bleeding complications. All patients will undergo a standard-of-care ultrasound examination with a focus on the description of the fibroid with atypical features according to the MUSA statement and/or Basel sarcoma scale score (BSS). A patient will be included in the study if she will meet one or more of the following MUSA criterion: irregular tumor borders, cystic areas in the lesion (as a sign of central necrosis), nonuniform echogenicity, moderate-to-abundant intralesional vascularity and an absence of calcifications, and/or BSS total score ≥ 1.

The patient will be further referred to MRI imaging (optional) and will undergo TCB within 4 weeks after US exam. In selected centers which will decide to participate in this optional part of the trial, all patients with ≥ 1 MUSA criterion and/or BSS total score ≥ 1 based on the US examination will be referred for MRI imaging. Images will be acquired with 3T MRI. The sequences parameters (Sagittal T2, Coronal T2, Axial T2, Axial DWI, Axial T1 3D DIXON, Axial Perfusion T1 3D, Axial T1 3D DIXON post contrast) will be evaluated in accordance with European Society of Urogenital Radiology (ESUR) guidelines. Two experienced readers in gynecologic oncology imaging will review all MRI images and calculate the MRI score.

The tru-cut biopsy is performed as an out-patient procedure without the need of any anesthesia in lithotomic position. Using an automatic biopsy gun and 18-gauge disposable core tissue biopsy needle four tissue cylinder samples are taken from the tumor. If the localization of the lesion and anatomical conditions allow, the transcervical approach without breaking the continuity of the perimetrium is preferred. If the lesion is localized in the uterine doom, or targetable by the uterine cavity, the transcervical canal approach is feasible and should be considered. If both above-described methods are not feasible, a transvaginal approach is also possible. In all cases transvaginal US is used for correct navigation. Patients will be observed for 30 minutes following the biopsy and then discharged. Other follow up of the patients will be done 24 hours and two weeks after the procedure via phone with the assessment of the patient´s pain, overall experience, and eventual complications.

Intraoperative and early post-procedural complications will be evaluated, and adverse events will be assessed on the 14th post-TCB day according to the Clavien-Dindo Surgical complications classification. Pain will be assessed during the TCB, 30 minutes after the procedure, and after 24 hours using the Numeric rating scale (NRS). Overall experience will be assessed using questionnaire: FACIT-TS-G (Version 4) 30 minutes after the procedure.