Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Nov 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called transvaginal tru-cut biopsy, which uses ultrasound to guide a needle into tumors located in the pelvis. The goal is to safely collect small tissue samples from these tumors in patients with various types of pelvic cancers, such as ovarian and cervical cancer. Researchers want to find out how safe and effective this method is for diagnosing and confirming the presence of cancer in a large group of women.

To participate in the trial, women aged 65 and older who have suspicious pelvic tumors that can be safely accessed for biopsy may be eligible. This includes those who are not able to undergo major surgery due to other health issues or the extent of their disease. Participants can expect to undergo the biopsy procedure in a controlled environment, where the collected tissue will be examined to help understand their condition better. It’s important to note that participants should not have certain health issues, such as bleeding disorders or active infections, which could complicate the procedure.

Gender

FEMALE

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:
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• • 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