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

200 Participants
are divided into 1 treatment group

Locations

4
Belgium
UZ Leuven Leuven Belgium
Czechia
First Faculty of Medicine, Charles University Prague Czechia
Italy
Fondazione Policlinico Universitario A. Gemelli, IRCSS Rome Italy
Sweden
Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset Stockholm Sweden

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