Trial Title:
Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.
NCT ID:
NCT05610501
Condition:
Pelvic Cancer
Ovarian Cancer
Cervical Cancer
Uterus Cancer
Endometrial Cancer
Ovarian Neoplasms
Ovarian Carcinoma
Sarcoma Uterus
Metastatic Cancer
Conditions: Official terms:
Ovarian Neoplasms
Endometrial Neoplasms
Pelvic Neoplasms
Uterine Neoplasms
Conditions: Keywords:
Tru-cut
Ultrasound
Pelvic mass
Ovarian cancer
Gynaecologic oncology
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Ultrasound guided tru-cut biopsy
Description:
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 group label:
Patient population
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
Criteria for eligibility:
Study pop:
All consecutive patients (> 18 years) undergoing a tru-cut biopsy at the collaborating
centers for a pelvic mass.
Sampling method:
Non-Probability Sample
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:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Wouter Froyman, MD, PhD
Phone:
+3216344202
Email:
wouter.froyman@uzleuven.be
Facility:
Name:
First Faculty of Medicine, Charles University
Address:
City:
Prague
Country:
Czechia
Status:
Not yet recruiting
Contact:
Last name:
Daniela Fischerova, MD, PHD
Email:
Daniela.Fischerova@vfn.cz
Facility:
Name:
Fondazione Policlinico Universitario A. Gemelli, IRCSS
Address:
City:
Rome
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Antonia Carla Testa, MD, PHD
Email:
antoniacarla.testa@unicatt.it
Facility:
Name:
Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset
Address:
City:
Stockholm
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Elisabeth Epstein, MD, PHD
Email:
elisabeth.epstein@regionstockholm.se
Start date:
May 1, 2021
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
UZ Leuven, Leuven, Belgium
Agency class:
Other
Collaborator:
Agency:
Policlinico Universitario A. Gemelli, IRCSS, Rome, Italy.
Agency class:
Other
Collaborator:
Agency:
First Faculty of Medicine, Charles University, Prague, Czech Republic.
Agency class:
Other
Collaborator:
Agency:
Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.
Agency class:
Other
Source:
Universitaire Ziekenhuizen KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05610501
