About this trial
In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination.
This clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.
Eligibility criteria
Qualifiers
Lesion safely accessible (no visceral or vessel interposition; in the case of a transvaginal approach no vaginal stenosis (severe atrophy - virgo - vaginismus); within reach of biopsy needle)
Solid component present (purely cystic lesions excluded)
Suspicious primary disseminated gynecologic tumor (tumor itself or metastasis) Patients with a presumable new diagnosis of a disseminated pelvic tumor where histological confirmation of disease is necessary before the possibility to start a specific oncologic treatment and
Are invalid candidates for primary (radical) surgery due to comorbidities or poor overall general wellbeing
Disqualifiers
None
Trial design
Treatments tested in this trial
- Ultrasound guided tru-cut biopsy
Treatment groups
Sponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
UZ Leuven, Leuven, Belgium
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Charles University, Czech Republic
Collaborator
Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.
Collaborator