Clinical trial NCT05610501: Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.
Official title: Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Cancer
Ovarian Cancer
Cervical Cancer
Uterus Cancer
Endometrial Cancer
Ovarian Neoplasms
Ovarian Carcinoma
Sarcoma Uterus
Metastatic Cancer
Keywords: Tru-cut
Ultrasound
Pelvic mass
Ovarian cancer
Gynaecologic oncology
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: UZ Leuven, Leuven, Belgium
name: Policlinico Universitario A. Gemelli, IRCSS, Rome, Italy.
name: First Faculty of Medicine, Charles University, Prague, Czech Republic.
name: Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.
First posted: 2022-11-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients (\> 18 years) undergoing a tru-cut biopsy at the collaborating centers for a pelvic mass.

Brief 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.

Detailed description: Ovarian cancer is known to be the 4th most lethal tumour in women and has the highest mortality rate of all gynaecological malignancies. In most women, the disease is not diagnosed until advanced stage \[1\]. Moreover, the pelvis and ovaries in particular, are also a common place for secondary metastases. In 4% of ovarian masses, metastasis can be found from a tumour with another primary origin \[2\]. In primary ovarian cancer, patients may benefit from either primary debulking surgery or neoadjuvant therapy, depending on tumour staging and patients' comorbidities \[5\]. In recurrent disease treatment may include surgery, radiotherapy or systemic therapy, depending on primary tumour histology, extent of recurrence, previous treatment and disease-free interval \[6-8\]. In pelvic masses with ultrasound features suggesting metastatic disease, management will be guided by the origin of the primary tumour \[9,10\]. Therefore, histological diagnosis is important to select the optimal treatment strategy.

Tissue sampling by diagnostic laparoscopy or explorative laparotomy requires general anaesthesia and hospital admission, leading to higher costs and to potential surgical morbidity. Moreover, diagnostic laparoscopy is associated with a risk of port-site metastasis, ranging from 0.3-0.4% in endometrial and cervical cancer \[11\] and even 17-49% in advanced ovarian cancer \[12,13\].

Minimally invasive procedures for diagnosis include fine-needle aspiration and tru-cut biopsy.

At fine-needle aspiration the quantity and integrity of the tissue is limited, enabling cytological evaluation only \[14\]. Tru-cut biopsy results in a higher specificity compared to fine needle biopsy and it enables histological examination including immunohistochemistry \[15,16\].

A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). However, percutaneous CT-guided biopsies of deep pelvic masses are challenging because vital structures often obstruct the needle pathway \[17\].

Previous studies have investigated the use of ultrasound-guided biopsies for the assessment of abdominal and pelvic masses which showed a high diagnostic adequacy and minimal complication rate \[4,16,18-25\]. This can be done by percutaneous transabdominal approach , a transvaginal or transrectal approach.

The main goal of this prospective study is to evaluate the safety and tissue yield of ultrasound guided transvaginal or transrectal tru-cut biopsy in patients with pelvic tumors. Secondly, factors affecting the reliability of the biopsy-results will be analyzed, as well as patients' experience and pain. Finally, a comparison of biopsy results and final histological diagnosis will be performed in those patients undergoing surgical management.

5. Study aims Primary Aim The main goal of our study is 1) to evaluate the safety (defined as absence of procedure-related complications) and 2) tissue yield (defined as sufficient amount of tissue for histological analysis) of ultrasound guided transvaginal or transrectal tru-cut biopsy in patients with pelvic masses.

Secondary Aims

* Analyzing factors affecting the safety and tissue yield. (The influence of selected variables such as number of biopsies per target lesion, length of the shot (15 vs 22 mm), thickness of needle (16-18 G), target lesion, target lesion size, histotypes etc. on these outcomes will be assessed.)
* Assessment of patients' overall experience, assessment of pain and discomfort during the procedure and afterwards.
* Comparison of biopsy result with final histological diagnosis: histological type (only in patients finally undergoing surgery)

Study design Prospective multicentric observational study

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

Primary outcomes:
measure: Safety
timeFrame: 6 weeks
measure: Tissue yield
timeFrame: 6 weeks after procedure
Secondary outcomes:
measure: Factor 1 affecting safety and tissue yield
timeFrame: 6 weeks
measure: Factor 2 affecting safety and tissue yield
timeFrame: 6 weeks
measure: Factor 3 affecting safety and tissue yield
timeFrame: 6 weeks
measure: Factor 4 affecting safety and tissue yield
timeFrame: 6 weeks
measure: Factor 5 affecting safety and tissue yield
timeFrame: 6 weeks
measure: Patient experience
timeFrame: 3 days
measure: Patient pain score
timeFrame: 3 days
measure: Histological diagnosis
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Prague
country: Czechia
facility: First Faculty of Medicine, Charles University
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli, IRCSS
city: Stockholm
country: Sweden
facility: Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset
Study officials:
References:
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