Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

July 1, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium
  • Czechia
      • Prague, Czechia
        • Not yet recruiting
        • First Faculty of Medicine, Charles University
        • Contact:
  • Italy
      • Rome, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario A. Gemelli, IRCSS
        • Contact:
  • Sweden
      • Stockholm, Sweden
        • Not yet recruiting
        • Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S64793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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