Focal Nodular Hyperplasia of LiverHepFocUSNCT01329458
Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions
An observational study of Focal Nodular Hyperplasia of Liver and Toxic Liver Disease With Focal Nodular Hyperplasia, run by Societatea Romana de Ultrasonografie in Medicina si Biologie at 5 sites in Romania.
Trial summary
The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Nodular Hyperplasia of Liver, Toxic Liver Disease With Focal Nodular Hyperplasia, Liver Metastases
- How many people
- 1,500 participants
- Where
- 5 sitesRomania
- Study dates
- Dec 2010to Dec 2011
- Phase
- Observational
- 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
Study population: The patients included in the study will be patients discovered with FLL at standard ultrasound. The focal lesions will be characterized by CEUS and the diagnosis established will be compared with the final diagnosis of the patient. The final diagnosis will be established based on all available imaging and clinical data: computer tomography, MRI, biopsy, follow up information.
Who may be able to join
- patients diagnosed with de novo FLL at standard ultrasound
- age > 18 years, male and female gender
- informed consent for the contrast enhanced study
Who cannot join
- patients with contraindication for contrast enhanced study: subjects with acute cardiac infarction, with class III/IV cardiac insufficiency, with rhythm disorders and pregnant women
- Patients diagnosed with simple cysts at standard ultrasound (biliary of hydatid)
- Patients with known FLL, for example after percutaneous treatment, in which the contrast study is used for the follow up of the patient.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Romania5 sites, 5 recruiting
- Recruiting
Institutul Clinic Fundeni
Bucharest
- Recruiting
Institutul Regional de Gastroenterologie-Hepatologie "Octavian Fodor",
Cluj-Napoca
- Recruiting
Clinica de Gastroenterologie Constanta
Constanța
- Recruiting
Centrul de Cercetare in Gastroenterologie si Hepatologie
Craiova
- Recruiting
Clinica de Gastroenterologie si Hepatologie
Timișoara
About this study
Official title: Contrast Enhanced Ultrasound for the Evaluation of Focal Liver Lesions - a Multi-center Study on the Usefulness in the Clinical Practice
The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design.
Read the detailed description
Focal liver lesions (FLL) are quite frequently discovered in daily practice at routine ultrasound and sometimes require the use of extensive investigations for a correct diagnosis, thus increasing the costs and duration of diagnosis. On the other hand, due to screening strategies for patients with liver cirrhosis, FLL are discovered very early in these patients, and they must be evaluated in order to establish a therapeutic strategy (including transplantation, surgical resection or percutaneous echoguided procedures).
Contrast enhanced ultrasound (CEUS) using second generation contrast agents is a relatively new imaging modality that allows the characterization of FLL and allows a positive diagnosis based on the vascular pattern of the lesion. The advantages of this method are the low cost as compared with other imaging modalities and the fact that it can be performed immediately after standard abdominal ultrasound, so approximately 5 minutes after CEUS (the total duration of this investigation) a confident diagnosis can be obtained.
The place of CEUS in the diagnostic algorithm of FLL is not very well established. The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) issued the first Guidelines regarding the use of CEUS in 2004, revised in 2008, in which the main indications of this method are presented.
The purpose of this study is to establish the value of CEUS in the evaluation of de novo FLL in clinical practice.
The study will include patients discovered with de novo FLL at standard ultrasound in which the ultrasound study is not conclusive for the positive diagnosis (the patients with simple cysts or known FLL under CEUS follow up will be excluded form the study). The standard ultrasound will be followed by the contrast study using SonoVue® (Bracco, Italy) as contrast agent. The amount of contrast agent will be documented in every patient (it depends on the ultrasound machine used and the suspected diagnosis). The examination will be performed using the dedicated contrast software of each ultrasound machine used in the study. The investigators shall also document in every patient: the indication for CEUS study, a short history including the presence of chronic hepatopathies or malignancies, the ultrasound machine used and the operator. Each examination will last about 5 min after bolus injection and will be documented by 4 video files no longer than 30 seconds each, containing: The standard study, the arterial phase, the portal phase and the late phase. Additional loops can be stored whenever it is considered necessary.
A CEUS diagnosis will be established based on the contrast study. This will be compared with the final diagnosis which will be established based on all available imaging and clinical data: computer tomography, MRI, biopsy, follow up information. A CEUS examination will be considered conclusive if, following contrast, the FLL had a typical enhancement pattern according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the lesions was not in concordance with this guide.
The stored loops will be also revised by different operators. The study design is prospective, multi-center and will be approved by the ethical review board.
- Conditions
- Focal Nodular Hyperplasia of Liver, Toxic Liver Disease With Focal Nodular Hyperplasia, Liver Metastases
- Keywords
- FLL, CEUS, SonoVue, HCC, Liver metastases, Hemangiomas, FNH
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Focal liver lesions | Focal liver lesions: patients discovered with new, uncharacteristic focal liver lesions at standard ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of contrast enhanced ultrasound in the assessment of de novo focal liver lesions
A CEUS examination will be considered conclusive if, following contrast, the FLL had a typical enhancement pattern according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the lesions was not in concordance with this guide.
Measured: 12 months evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Focal Nodular Hyperplasia of LiverStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societatea Romana de Ultrasonografie in Medicina si Biologie
- Sponsor type
- University, hospital or other
- Collaborators
- Centrul de Cercetare in Gastroenterologie si Hepatologie, Craiova, Clinica de Gastroenterologie si Hepatologie, UMF Timisoara, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Institutul Clinic Fundeni, Clinica de Gastroenterologie Constanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329458
- Sponsor's protocol ID
- HepFocUS
- Acronym
- HepFocUS
- Status last verified
- Apr 2011
- First submitted
- 2 Apr 2011
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Albrecht T, Blomley M, Bolondi L, Claudon M, Correas JM, Cosgrove D, Greiner L, Jager K, Jong ND, Leen E, Lencioni R, Lindsell D, Martegani A, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T; EFSUMB Study Group. Guidelines for the use of contrast agents in ultrasound. January 2004. Ultraschall Med. 2004 Aug;25(4):249-56. doi: 10.1055/s-2004-813245. No abstract available.
PubMed 15300497Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, Correas JM, Darge K, Dietrich C, D'Onofrio M, Evans DH, Filice C, Greiner L, Jager K, Jong Nd, Leen E, Lencioni R, Lindsell D, Martegani A, Meairs S, Nolsoe C, Piscaglia F, Ricci P, Seidel G, Skjoldbye B, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) - update 2008. Ultraschall Med. 2008 Feb;29(1):28-44. doi: 10.1055/s-2007-963785. No abstract available.
PubMed 18270887Strobel D, Seitz K, Blank W, Schuler A, Dietrich C, von Herbay A, Friedrich-Rust M, Kunze G, Becker D, Will U, Kratzer W, Albert FW, Pachmann C, Dirks K, Strunk H, Greis C, Bernatik T. Contrast-enhanced ultrasound for the characterization of focal liver lesions--diagnostic accuracy in clinical practice (DEGUM multicenter trial). Ultraschall Med. 2008 Oct;29(5):499-505. doi: 10.1055/s-2008-1027806.
PubMed 19241506Tranquart F, Correas JM, Ladam Marcus V, Manzoni P, Vilgrain V, Aube C, Elmaleh A, Chami L, Claudon M, Cuilleron M, Diris B, Garibaldi F, Lucidarme O, Marion D, Beziat C, Rode A, Tasu JP, Trillaud H, Bleuzen A, Le Gouge A, Giraudeau B, Rusch E. [Real-time contrast-enhanced ultrasound in the evaluation of focal liver lesions: diagnostic efficacy and economical issues from a French multicentric study]. J Radiol. 2009 Jan;90(1 Pt 2):109-22. doi: 10.1016/s0221-0363(09)70089-7. French.
PubMed 19212279Braun B. Focal liver processes: "better is the enemy of good": CEUS in the fast lane. Ultraschall Med. 2009 Aug;30(4):329-32. doi: 10.1055/s-0028-1109693. Epub 2009 Aug 17. No abstract available. English, German.
PubMed 19688667Wilson SR, Greenbaum LD, Goldberg BB. Contrast-enhanced ultrasound: what is the evidence and what are the obstacles? AJR Am J Roentgenol. 2009 Jul;193(1):55-60. doi: 10.2214/AJR.09.2553.
PubMed 19542395Trillaud H, Bruel JM, Valette PJ, Vilgrain V, Schmutz G, Oyen R, Jakubowski W, Danes J, Valek V, Greis C. Characterization of focal liver lesions with SonoVue-enhanced sonography: international multicenter-study in comparison to CT and MRI. World J Gastroenterol. 2009 Aug 14;15(30):3748-56. doi: 10.3748/wjg.15.3748.
PubMed 19673015Quaia E, Calliada F, Bertolotto M, Rossi S, Garioni L, Rosa L, Pozzi-Mucelli R. Characterization of focal liver lesions with contrast-specific US modes and a sulfur hexafluoride-filled microbubble contrast agent: diagnostic performance and confidence. Radiology. 2004 Aug;232(2):420-30. doi: 10.1148/radiol.2322031401.
PubMed 15286314von Herbay A, Vogt C, Willers R, Haussinger D. Real-time imaging with the sonographic contrast agent SonoVue: differentiation between benign and malignant hepatic lesions. J Ultrasound Med. 2004 Dec;23(12):1557-68. doi: 10.7863/jum.2004.23.12.1557.
PubMed 15557299Sirli R, Sporea I, Popescu A, Danila M, Sandulescu DL, Saftoiu A, Moga T, Sparchez Z, Cijevschi C, Mihai C, Ioanitescu S, Nedelcu D, Iacob N, Miclaus G, Brisc C, Badea R. Contrast-enhanced ultrasound for the assessment of focal nodular hyperplasia - results of a multicentre study. Med Ultrason. 2021 May 20;23(2):140-146. doi: 10.11152/mu-2912. Epub 2021 Apr 22.
PubMed 33945596Sporea I, Sandulescu DL, Sirli R, Popescu A, Danila M, Sparchez Z, Mihai C, Ioanitescu S, Moga T, Timar B, Brisc C, Nedelcu D, Saftoiu A, Enachescu V, Badea R. Contrast-Enhanced Ultrasound for the Characterization of Malignant versus Benign Focal Liver Lesions in a Prospective Multicenter Experience - The SRUMB Study. J Gastrointestin Liver Dis. 2019 Jun 1;28:191-196. doi: 10.15403/jgld-180.
PubMed 31204417Sirli R, Sporea I, Sandulescu DL, Popescu A, Danila M, Saftoiu A, Sparchez Z, Badea R. Contrast enhanced ultrasound for the diagnosis of liver hemangiomas - results of a Romanian multicentre study. Med Ultrason. 2015 Dec;17(4):444-50. doi: 10.11152/mu.2013.2066.174.csu.
PubMed 26649337
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound for the Evaluation of Focal Liver Lesions - a Multi-center Study on the Usefulness in the Clinical Practice
- ClinicalTrials.gov ID
- NCT01329458
- Acronym / sponsor ID
- HepFocUS / HepFocUS
- Conditions
- Focal Nodular Hyperplasia of Liver, Toxic Liver Disease With Focal Nodular Hyperplasia, Liver Metastases
- Keywords
- FLL, CEUS, SonoVue, HCC, Liver metastases, Hemangiomas, FNH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Societatea Romana de Ultrasonografie in Medicina si BiologieUniversity, hospital or other
- Collaborators
- Centrul de Cercetare in Gastroenterologie si Hepatologie, Craiova, Clinica de Gastroenterologie si Hepatologie, UMF Timisoara, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Institutul Clinic Fundeni, Clinica de Gastroenterologie Constanta
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 6 Apr 2011 (estimated)
- 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.
The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design.
Detailed description
Focal liver lesions (FLL) are quite frequently discovered in daily practice at routine ultrasound and sometimes require the use of extensive investigations for a correct diagnosis, thus increasing the costs and duration of diagnosis. On the other hand, due to screening strategies for patients with liver cirrhosis, FLL are discovered very early in these patients, and they must be evaluated in order to establish a therapeutic strategy (including transplantation, surgical resection or percutaneous echoguided procedures).
Contrast enhanced ultrasound (CEUS) using second generation contrast agents is a relatively new imaging modality that allows the characterization of FLL and allows a positive diagnosis based on the vascular pattern of the lesion. The advantages of this method are the low cost as compared with other imaging modalities and the fact that it can be performed immediately after standard abdominal ultrasound, so approximately 5 minutes after CEUS (the total duration of this investigation) a confident diagnosis can be obtained.
The place of CEUS in the diagnostic algorithm of FLL is not very well established. The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) issued the first Guidelines regarding the use of CEUS in 2004, revised in 2008, in which the main indications of this method are presented.
The purpose of this study is to establish the value of CEUS in the evaluation of de novo FLL in clinical practice.
The study will include patients discovered with de novo FLL at standard ultrasound in which the ultrasound study is not conclusive for the positive diagnosis (the patients with simple cysts or known FLL under CEUS follow up will be excluded form the study). The standard ultrasound will be followed by the contrast study using SonoVue® (Bracco, Italy) as contrast agent. The amount of contrast agent will be documented in every patient (it depends on the ultrasound machine used and the suspected diagnosis). The examination will be performed using the dedicated contrast software of each ultrasound machine used in the study. The investigators shall also document in every patient: the indication for CEUS study, a short history including the presence of chronic hepatopathies or malignancies, the ultrasound machine used and the operator. Each examination will last about 5 min after bolus injection and will be documented by 4 video files no longer than 30 seconds each, containing: The standard study, the arterial phase, the portal phase and the late phase. Additional loops can be stored whenever it is considered necessary.
A CEUS diagnosis will be established based on the contrast study. This will be compared with the final diagnosis which will be established based on all available imaging and clinical data: computer tomography, MRI, biopsy, follow up information. A CEUS examination will be considered conclusive if, following contrast, the FLL had a typical enhancement pattern according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the lesions was not in concordance with this guide.
The stored loops will be also revised by different operators. The study design is prospective, multi-center and will be approved by the ethical review board.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal liver lesions | – | –Focal liver lesions: patients discovered with new, uncharacteristic focal liver lesions at standard ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study will be patients discovered with FLL at standard ultrasound. The focal lesions will be characterized by CEUS and the diagnosis established will be compared with the final diagnosis of the patient. The final diagnosis will be established based on all available imaging and clinical data: computer tomography, MRI, biopsy, follow up information.
Key inclusion criteria (3 listed)
- patients diagnosed with de novo FLL at standard ultrasound
- age > 18 years, male and female gender
- informed consent for the contrast enhanced study
Key exclusion criteria (3 listed)
- patients with contraindication for contrast enhanced study: subjects with acute cardiac infarction, with class III/IV cardiac insufficiency, with rhythm disorders and pregnant women
- Patients diagnosed with simple cysts at standard ultrasound (biliary of hydatid)
- Patients with known FLL, for example after percutaneous treatment, in which the contrast study is used for the follow up of the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of contrast enhanced ultrasound in the assessment of de novo focal liver lesions
Time frame: 12 months evaluation
A CEUS examination will be considered conclusive if, following contrast, the FLL had a typical enhancement pattern according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the lesions was not in concordance with this guide.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
- Background: PubMed 15300497Albrecht T, Blomley M, Bolondi L, Claudon M, Correas JM, Cosgrove D, Greiner L, Jager K, Jong ND, Leen E, Lencioni R, Lindsell D, Martegani A, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T; EFSUMB Study Group. Guidelines for the use of contrast agents in ultrasound. January 2004. Ultraschall Med. 2004 Aug;25(4):249-56. doi: 10.1055/s-2004-813245. No abstract available.
- Background: PubMed 18270887Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, Correas JM, Darge K, Dietrich C, D'Onofrio M, Evans DH, Filice C, Greiner L, Jager K, Jong Nd, Leen E, Lencioni R, Lindsell D, Martegani A, Meairs S, Nolsoe C, Piscaglia F, Ricci P, Seidel G, Skjoldbye B, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) - update 2008. Ultraschall Med. 2008 Feb;29(1):28-44. doi: 10.1055/s-2007-963785. No abstract available.
- Background: PubMed 19241506Strobel D, Seitz K, Blank W, Schuler A, Dietrich C, von Herbay A, Friedrich-Rust M, Kunze G, Becker D, Will U, Kratzer W, Albert FW, Pachmann C, Dirks K, Strunk H, Greis C, Bernatik T. Contrast-enhanced ultrasound for the characterization of focal liver lesions--diagnostic accuracy in clinical practice (DEGUM multicenter trial). Ultraschall Med. 2008 Oct;29(5):499-505. doi: 10.1055/s-2008-1027806.
- Background: PubMed 19212279Tranquart F, Correas JM, Ladam Marcus V, Manzoni P, Vilgrain V, Aube C, Elmaleh A, Chami L, Claudon M, Cuilleron M, Diris B, Garibaldi F, Lucidarme O, Marion D, Beziat C, Rode A, Tasu JP, Trillaud H, Bleuzen A, Le Gouge A, Giraudeau B, Rusch E. [Real-time contrast-enhanced ultrasound in the evaluation of focal liver lesions: diagnostic efficacy and economical issues from a French multicentric study]. J Radiol. 2009 Jan;90(1 Pt 2):109-22. doi: 10.1016/s0221-0363(09)70089-7. French.
- Background: PubMed 19688667Braun B. Focal liver processes: "better is the enemy of good": CEUS in the fast lane. Ultraschall Med. 2009 Aug;30(4):329-32. doi: 10.1055/s-0028-1109693. Epub 2009 Aug 17. No abstract available. English, German.
- Background: PubMed 19542395Wilson SR, Greenbaum LD, Goldberg BB. Contrast-enhanced ultrasound: what is the evidence and what are the obstacles? AJR Am J Roentgenol. 2009 Jul;193(1):55-60. doi: 10.2214/AJR.09.2553.
- Background: PubMed 19673015Trillaud H, Bruel JM, Valette PJ, Vilgrain V, Schmutz G, Oyen R, Jakubowski W, Danes J, Valek V, Greis C. Characterization of focal liver lesions with SonoVue-enhanced sonography: international multicenter-study in comparison to CT and MRI. World J Gastroenterol. 2009 Aug 14;15(30):3748-56. doi: 10.3748/wjg.15.3748.
- Background: PubMed 15286314Quaia E, Calliada F, Bertolotto M, Rossi S, Garioni L, Rosa L, Pozzi-Mucelli R. Characterization of focal liver lesions with contrast-specific US modes and a sulfur hexafluoride-filled microbubble contrast agent: diagnostic performance and confidence. Radiology. 2004 Aug;232(2):420-30. doi: 10.1148/radiol.2322031401.
- Background: PubMed 15557299von Herbay A, Vogt C, Willers R, Haussinger D. Real-time imaging with the sonographic contrast agent SonoVue: differentiation between benign and malignant hepatic lesions. J Ultrasound Med. 2004 Dec;23(12):1557-68. doi: 10.7863/jum.2004.23.12.1557.
- Derived from this study: PubMed 33945596Sirli R, Sporea I, Popescu A, Danila M, Sandulescu DL, Saftoiu A, Moga T, Sparchez Z, Cijevschi C, Mihai C, Ioanitescu S, Nedelcu D, Iacob N, Miclaus G, Brisc C, Badea R. Contrast-enhanced ultrasound for the assessment of focal nodular hyperplasia - results of a multicentre study. Med Ultrason. 2021 May 20;23(2):140-146. doi: 10.11152/mu-2912. Epub 2021 Apr 22.
- Derived from this study: PubMed 31204417Sporea I, Sandulescu DL, Sirli R, Popescu A, Danila M, Sparchez Z, Mihai C, Ioanitescu S, Moga T, Timar B, Brisc C, Nedelcu D, Saftoiu A, Enachescu V, Badea R. Contrast-Enhanced Ultrasound for the Characterization of Malignant versus Benign Focal Liver Lesions in a Prospective Multicenter Experience - The SRUMB Study. J Gastrointestin Liver Dis. 2019 Jun 1;28:191-196. doi: 10.15403/jgld-180.
- Derived from this study: PubMed 26649337Sirli R, Sporea I, Sandulescu DL, Popescu A, Danila M, Saftoiu A, Sparchez Z, Badea R. Contrast enhanced ultrasound for the diagnosis of liver hemangiomas - results of a Romanian multicentre study. Med Ultrason. 2015 Dec;17(4):444-50. doi: 10.11152/mu.2013.2066.174.csu.
- Related InfoLink provided by the sponsor.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Nodular Hyperplasia of Liver and Toxic Liver Disease With Focal Nodular Hyperplasia, run by Societatea Romana de Ultrasonografie in Medicina si Biologie at 5 sites 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 3 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: status not confirmed, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihai A Socaciu, MD, PhD student (0040745587847, socacium@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of contrast enhanced ultrasound in the assessment of de novo focal liver lesions (time frame: 12 months evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01329458, which also lists 12 linked publications.
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 6 Apr 2011.