Actively Recruiting

Age: 18Years +
FEMALE
ID05610501

Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

200

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

U

UZ Leuven, Leuven, Belgium

Collaborating Sponsor

AI-Summary

What this Trial Is About

Ovarian cancer is a leading cause of death among gynecological cancers, often diagnosed late and sometimes involving metastases from other primary tumors. This research aims to evaluate the safety and tissue yield of ultrasound-guided transvaginal or transrectal tru-cut biopsy in patients with pelvic tumors. The study also looks at factors influencing biopsy reliability, patient experience, pain, and compares biopsy results to final surgical histology when available. Participants undergo a minimally invasive tru-cut biopsy using an 18G needle guided by ultrasound to collect tissue samples from pelvic masses. The biopsies are performed by experienced gynecologic ultrasound operators, and tissue is analyzed by specialized pathologists. The study is observational and collects data on safety, tissue adequacy, patient pain and experience, and correlates biopsy findings with surgery outcomes if applicable. During the study, patients' pain and overall experience are assessed within 72 hours post-biopsy using a numeric rating scale. Safety and complication rates are monitored up to six weeks after the procedure through data review and follow-up assessments including phone calls. The main outcomes measured at six weeks are safety (absence of complications) and tissue yield (sufficient tissue for analysis). Secondary outcomes include factors affecting these results, patient discomfort, and histological diagnosis accuracy.

CONDITIONS

Brief Title

Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Female gender
  • Lesion safely accessible for biopsy without risk to vital organs or vessels
  • No vaginal stenosis, severe atrophy, or vaginismus preventing transvaginal biopsy
  • Presence of a solid component in the pelvic lesion (purely cystic lesions excluded)
  • For research biopsies: diagnosed gynecologic tumor eligible for biopsy in clinical trials
  • For diagnostic biopsies: suspicious primary or recurrent gynecologic or non-gynecologic tumors requiring histological confirmation before treatment
  • Solitary tumor of unknown histology in vaginal wall, parametria, retroperitoneum, or uterine wall that can be safely punctured without spilling
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Blood clotting disorders or anticoagulation therapy that precludes safe biopsy
  • Vaginal or pelvic infection
  • Poor performance status that contraindicates oncologic treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and informed consent

Diagnostic Evaluation

Duration - Day of biopsy procedure and up to 3 days afterwards

Participants undergo an ultrasound-guided tru-cut biopsy to collect tissue samples from pelvic masses for histological analysis and to evaluate safety and tissue yield.

1 biopsy procedure visit plus follow-up pain and experience assessment within 3 days

Safety and Outcome Monitoring

Duration - 6 weeks

Participants are monitored for procedure-related complications and biopsy tissue adequacy, with clinical data collected and assessed up to 6 weeks after the biopsy.

Post-procedure assessment and phone follow-up approximately 6 weeks after biopsy

Trial Site Locations

Total: 4 locations

1

UZ Leuven

Leuven, Belgium

Actively Recruiting

2

First Faculty of Medicine, Charles University

Prague, Czechia

Not Yet Recruiting

3

Fondazione Policlinico Universitario A. Gemelli, IRCSS

Rome, Italy

Not Yet Recruiting

4

Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset

Stockholm, Sweden

Not Yet Recruiting

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Research Team

W

Wouter Froyman, MD, PHD

S

Stefan Timmerman, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Evaluating the risk of ovarian cancer before surgery using the ADNEX model to differentiate between benign, borderline, early and advanced stage invasive, and secondary metastatic tumours: prospective multicentre diagnostic study.

Ben Van Calster, Kirsten Van Hoorde, Lil Valentin...

https://pubmed.ncbi.nlm.nih.gov/25320247

Imaging in gynecological disease (1): ultrasound features of metastases in the ovaries differ depending on the origin of the primary tumor.

A C Testa, G Ferrandina, D Timmerman...

https://pubmed.ncbi.nlm.nih.gov/17444565

Subjective ultrasound assessment, the ADNEX model and ultrasound-guided tru-cut biopsy to differentiate disseminated primary ovarian cancer from metastatic non-ovarian cancer.

E Epstein, B Van Calster, D Timmerman...

https://pubmed.ncbi.nlm.nih.gov/25925783

Practical guidance for applying the ADNEX model from the IOTA group to discriminate between different subtypes of adnexal tumors.

B Van Calster, K Van Hoorde, W Froyman...

https://pubmed.ncbi.nlm.nih.gov/25897370