Actively Recruiting
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
208 weeks
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
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.
CONDITIONS
Official Title
Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lesion accessible for biopsy without obstruction by organs or vessels; for transvaginal approach, no severe vaginal narrowing, atrophy, or vaginismus; lesion within needle reach
- Lesion has a solid component; purely cystic lesions are excluded
- Patients needing biopsy for participation in clinical trials on gynecological tumors requiring tissue for translational research
- Patients with suspicious primary disseminated gynecologic tumors unsuitable for primary surgery due to comorbidities or extensive disease
- Patients with suspicious primary disseminated non-gynecologic tumors requiring histological confirmation
- Patients with possible recurrence of gynecological tumors needing confirmation before treatment
- Patients with possible recurrence of non-gynecological tumors needing confirmation before treatment
- Patients with solitary tumor of unknown type in vaginal wall, parametria, retroperitoneum, or uterine wall suitable for biopsy without risk of abdominal spillage
You will not qualify if you...
- Patients younger than 18 years
- Clotting disorders or anticoagulation therapy that prevent safe biopsy despite adjusted treatment
- Vaginal or pelvic infections
- Poor overall health status preventing oncologic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
W
Wouter Froyman, MD, PHD
CONTACT
S
Stefan Timmerman, MD
CONTACT
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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