Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT05610501

Collaborator

UZ Leuven, Leuven, Belgium (Other), Policlinico Universitario A. Gemelli, IRCSS, Rome, Italy. (Other), First Faculty of Medicine, Charles University, Prague, Czech Republic. (Other), Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden. (Other)

200

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Cancer Ovarian Cancer Cervical Cancer Uterus Cancer Endometrial Cancer Ovarian Neoplasms Ovarian Carcinoma Sarcoma Uterus Metastatic Cancer	Procedure: Ultrasound guided tru-cut biopsy

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.

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patient population All consecutive patients (> 18 years) undergoing a tru-cut biopsy at the participating centers during the study periof will be eligible for inclusion in the study. All biopsies will be performed by trained operators in gynecologic ultrasound and tru-cut biopsies. Tissue samples will be assessed by experienced pathologists, dedicated in gynecologic oncology. Data will be collected by reviewing patients' electronic medical file including data concerning further treatment-strategy and pathology reports. Patients' level of pain and overall experience will be assessed by an independent investigator not present during biopsy. This will be performed from 0-72h after the biopsy using a numeric rating scale (0-100). Safety and complication-rate will be assessed by both using the collected data and via postprocedural assessment and by phone after six weeks. Inclusion and exclusion criteria can be found elsewhere.	Procedure: Ultrasound 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

Arm

Intervention/Treatment

Patient population

All consecutive patients (> 18 years) undergoing a tru-cut biopsy at the participating centers during the study periof will be eligible for inclusion in the study. All biopsies will be performed by trained operators in gynecologic ultrasound and tru-cut biopsies. Tissue samples will be assessed by experienced pathologists, dedicated in gynecologic oncology. Data will be collected by reviewing patients' electronic medical file including data concerning further treatment-strategy and pathology reports. Patients' level of pain and overall experience will be assessed by an independent investigator not present during biopsy. This will be performed from 0-72h after the biopsy using a numeric rating scale (0-100). Safety and complication-rate will be assessed by both using the collected data and via postprocedural assessment and by phone after six weeks. Inclusion and exclusion criteria can be found elsewhere.

Procedure: Ultrasound 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

Outcome Measures

Primary Outcome Measures

Safety [6 weeks]
Defined as absence of procedure-related complications. Procedure related complications will be graded by Clavien-Dindo classification.
Tissue yield [6 weeks after procedure]
Defined as sufficient amount of tissue for histological analysis. This will be a binary variable based on the pathology report.

Secondary Outcome Measures

Factor 1 affecting safety and tissue yield [6 weeks]
A number of biopsies per target lesion,
Factor 2 affecting safety and tissue yield [6 weeks]
The length of the needle shot (15 vs 22 mm).
Factor 3 affecting safety and tissue yield [6 weeks]
The thickness of needle (16-18 Gauge).
Factor 4 affecting safety and tissue yield [6 weeks]
The target lesion histotype - categorical variable defined by the tumour type.
Factor 5 affecting safety and tissue yield [6 weeks]
The target lesion size in mm.
Patient experience [3 days]
Assessment of patients' overall experience using VAS-Score.
Patient pain score [3 days]
Assessment of patients' pain and discomfort during the procedure using VAS-Score.
Histological diagnosis [6 weeks]
Comparison of biopsy result with final histological diagnosis: histological type (only in patients finally undergoing surgery). Binary variable indicating agreement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1. 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.
In case of a diagnostic biopsy, one of the following inclusion criteria should be applicable:
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 Criteria:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Universitaire Ziekenhuizen KU Leuven
UZ Leuven, Leuven, Belgium
Policlinico Universitario A. Gemelli, IRCSS, Rome, Italy.
First Faculty of Medicine, Charles University, Prague, Czech Republic.
Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.