RecruitingNCT05610501

Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

200 participants

Start Date

May 1, 2021

Study Type

OBSERVATIONAL

Conditions

Ovarian Cancer Cervical Cancer Endometrial Cancer Ovarian Carcinoma Ovarian Neoplasms Metastatic Cancer Pelvic Cancer Uterus Cancer Sarcoma Uterus

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

\. Following lesion criteria applicable for biopsy:
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)
\. Biopsy for research purposes, the following is applicable: Patients with a gynecological tumor eligible for participation in academic or commercial clinical trials requesting a biopsy for translational research. For the current study, which is observational, we do not intend to take additional biopsies outside routine clinical practice, but only biopsies requested for participation in other (interventional) studies on systemic treatment in gynecologic oncology.
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
Are invalid candidates for primary (radical) surgery due to the extensive disease-spread according to imaging and/or diagnostic laparoscopy
Suspicious primary disseminated NON-gynecologic tumor (tumor itself or metastasis)
Patients with possible recurrence of a gynecological tumor (cervix, myometrial, endometrial, ovarian etc), where histological confirmation of disease recurrence is necessary before the possibility to start a surgical or systemic intervention.
Patients with possible recurrence of a presumably non-gynecological tumor, where histological confirmation of disease recurrence is necessary before start of treatment.
Solitary tumor of unknown histology localized in vaginal wall, parametria, retroperitoneum or uterine wall and can be punctured without spilling in abdominal cavity.

Exclusion Criteria2

\- 1. Patients \< 18 years 2. Clotting defect or anticoagulation therapy, precluding a safe biopsy even with adapted therapy regimen.
\. Vaginal or pelvic infection 4. Poor performance status contraindicating any specific oncologic treatment

Interventions

PROCEDUREUltrasound guided tru-cut biopsy

Tru-cut biopsies can collect tissue specimens via a needle of 18G A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound