Retroperitoneal NeoplasmsNCT05659433
Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors
A study testing CEUS-guided percutaneous biopsy and B-mode US-guided percutaneous biopsy in people with Retroperitoneal Neoplasms, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Neoplasms
- What is being tested?
- CEUS-guided percutaneous biopsy and B-mode US-guided percutaneous biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2015to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with retroperitoneal tumors with indication for percutaneous biopsy
Who cannot join
- Tumors inaccessible for ultrasound guided biopsy
- Standard contraindications for biopsy (altered coagulation tests, poor performance status)
- Lack of written informed consent
Trial locations and contacts
1 site in 1 country.
Romania1 site
Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Cluj, 400162
About this study
Official title: Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial
Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate).
Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area.
Read more
Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events.
Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy.
The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.
- Conditions
- Retroperitoneal Neoplasms
- Being tested
- CEUS-guided percutaneous biopsy, B-mode US-guided percutaneous biopsy
- Keywords
- Percutaneous biopsy, Contrast-enhanced ultrasonography, CEUS, Retroperitoneal neoplasms
- Medical subject headings
- Retroperitoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEUS-guided percutaneous biopsyProcedure or surgery
A standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized)
B-mode US-guided percutaneous biopsyProcedure or surgery
Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement
| Study group | Role | What they receive |
|---|---|---|
| B-mode Ultrasound-guided Biopsy | Active comparator | Not described Receives: Procedure: B-mode US-guided percutaneous biopsy |
| Contrast-enhanced Ultrasound-guided Biopsy | Experimental | Not described Receives: Procedure: CEUS-guided percutaneous biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a biopsy sample adequate for pathology interpretation
Measured: 4 weeks
Secondary outcomes (2)
Number of patients requiring a second biopsy due to prior inadequate sampling
Measured: 6 weeks
Number of patients with procedural-related adverse events
Bleeding, hematoma, puncture-site infection, prolonged hospitalisation
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jan 2015
- Primary completion15 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Responsible party
- Principal investigator, Rareș Crăciun, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Zeno Spârchez, MD, Prof., Study chair, Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659433
- Sponsor's protocol ID
- CEUS-PBRT
- Status last verified
- Dec 2022
- First submitted
- 3 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05659433
- Acronym / sponsor ID
- CEUS-PBRT
- Conditions
- Retroperitoneal Neoplasms
- Keywords
- Percutaneous biopsy, Contrast-enhanced ultrasonography, CEUS, Retroperitoneal neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate).
Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area.
Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events.
Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy.
The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-mode Ultrasound-guided Biopsy | Active comparator | Procedure: B-mode US-guided percutaneous biopsy |
| Contrast-enhanced Ultrasound-guided Biopsy | Experimental | Procedure: CEUS-guided percutaneous biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with retroperitoneal tumors with indication for percutaneous biopsy
Key exclusion criteria (3 listed)
- Tumors inaccessible for ultrasound guided biopsy
- Standard contraindications for biopsy (altered coagulation tests, poor performance status)
- Lack of written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEUS-guided percutaneous biopsyA standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized) | Procedure or surgery | Contrast-enhanced Ultrasound-guided Biopsy |
| B-mode US-guided percutaneous biopsyStandard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement | Procedure or surgery | B-mode Ultrasound-guided Biopsy |
Primary outcome
Number of patients with a biopsy sample adequate for pathology interpretation
Time frame: 4 weeks
2 secondary outcomes
Number of patients requiring a second biopsy due to prior inadequate sampling
Time frame: 6 weeks
Number of patients with procedural-related adverse events
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeno Spârchez, MD, Prof. study chair
Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEUS-guided percutaneous biopsy and B-mode US-guided percutaneous biopsy in people with Retroperitoneal Neoplasms, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a biopsy sample adequate for pathology interpretation (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.