Ultrasound-guided biopsy for pelvic masses

Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

This study is testing a new way to safely take tissue samples from pelvic tumors using ultrasound to help improve diagnosis and treatment for women with these masses.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Locations: 4 sites (Leuven and 3 other locations)
• Trial ID: NCT05610501 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the safety and efficacy of transvaginal tru-cut biopsy guided by ultrasound in patients with pelvic masses. The procedure involves inserting a needle through the vaginal wall to obtain tissue samples from tumors for histological examination. By focusing on patients with gynecological tumors, the study aims to improve diagnostic accuracy and treatment strategies while minimizing the risks associated with more invasive procedures. The research will help determine the optimal management of pelvic masses, particularly in cases of suspected metastatic disease.

Who should consider this trial

Good fit: Ideal candidates include women with solid pelvic masses that are accessible for biopsy and who are eligible for participation in clinical trials.

Not a fit: Patients with purely cystic lesions or those with significant vaginal stenosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses and tailored treatment plans for patients with pelvic cancers.

How similar studies have performed: Other studies have shown promising results with minimally invasive biopsy techniques, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 1\. Following lesion criteria applicable for biopsy:

  1. 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)
  2. Solid component present (purely cystic lesions excluded)

     2\. 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.

     3\. In case of a diagnostic biopsy, one of the following inclusion criteria should be applicable:

  <!-- -->

  1. 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
  2. Suspicious primary disseminated NON-gynecologic tumor (tumor itself or metastasis)
  3. 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.
  4. Patients with possible recurrence of a presumably non-gynecological tumor, where histological confirmation of disease recurrence is necessary before start of treatment.
  5. Solitary tumor of unknown histology localized in vaginal wall, parametria, retroperitoneum or uterine wall and can be punctured without spilling in abdominal cavity.

Exclusion Criteria:

\- 1. Patients \< 18 years 2. Clotting defect or anticoagulation therapy, precluding a safe biopsy even with adapted therapy regimen.

3\. Vaginal or pelvic infection 4. Poor performance status contraindicating any specific oncologic treatment

Where this trial is running

Leuven and 3 other locations

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

Study contacts

• Study coordinator: Wouter Froyman, MD, PHD

Conditions: Pelvic Cancer, Ovarian Cancer, Cervical Cancer, Uterus Cancer, Endometrial Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Sarcoma Uterus