Evaluation of Complex Renal Cyst With CEUS/Functional MRI Versus CT

NCT02371551 | Completed

• 1 other identifier: 84/14
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The primary concern in complex renal cysts (CRC) with malignant potential is the accurate diagnosis and characterization. Patients with CRC have to undergo frequent imaging surveillance (every 6-12 Mo), in which the progression suggests a neoplastic process. The gold standard for establishing diagnosis and necessity for surgical intervention (i.e. partial nephrectomy) is conventional computer tomography (CT) imaging. Its main drawback is the radiation dose to the body and intravenous contrast media administration, which has a risk of nephrotoxicity. Magnetic resonance imaging (MRI) with special functional sequences (fMRI) and contrast-enhanced ultrasonography (CEUS) allow measuring tissue blood flow and perfusion characteristics without ionizing radiation or nephrotoxic contrast media. To compare the diagnostic accuracy, sensitivity and specificity of CEUS/functional MRI versus the gold standard CT, 60 patients with CRC will be evaluated using all these 3 modalities. The main hypothesis is that fMRI and CEUS have equal accuracy with CT regarding diagnosis and classification of CRC lesions.

Conditions

Cystic Renal Diseases; Kidney Neoplasms

Keywords

Diffusion Magnetic Resonance Imaging; Medical Sonography; Computed Tomography, X-Ray

Outcome Measures

Primary Outcomes (1)

• CRC classification according to CT-finding based on Bosniak criteria or until surgical intervention

  1 year

Secondary Outcomes (2)

• Diagnostic accuracy of CEUS and fMRI based on the progression of CRC according to CT-finding and Bosniak classification throughout visit 1-2

  1 year

• Diagnostic accuracy of CEUS and fMRI based on surgical extraction and histopathological evaluation of the resected mass

  1 year

Study Arms (1)

1

All patients

Other: Blood/urine sampling; Other: Conventional routine CT examination; Other: Contrast-enhanced renal ultrasonography (CEUS); Other: Functional MRI

Interventions

Blood/urine sampling OTHER

Routine chemistry profile

1

Conventional routine CT examination OTHER

Standard diagnostic examination

1

Contrast-enhanced renal ultrasonography (CEUS) OTHER

Study-specific diagnostic examination

1

Functional MRI OTHER

Study-specific diagnostic examination

1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were referred to the outpatient clinic of the Department of Nephrology or to the Department of Urology, Bern University Hospital for the clarification of a complex renal cyst/lesion and already underwent or will undergo a standard CT examination or patient who where accidentally diagnosed with a complicated renal cyst/lesion from the Department of Nephrology, Urology or Radiology (with CT imaging)

You may qualify if:

• Age \> 18 years old
• Written informed consent
• A complicated renal cyst (Bosniak category \> II cyst or hemorrhagic cyst) or lesion \> 1 cm im max. transverse diameter who will undergo standard renal CT imaging
• Stable renal function (GFR\> 30 ml/min/1.73 m2)

You may not qualify if:

• Pregnancy
• History of allergic reaction to contrast agents
• Refusal to adhere to follow-up
• Recent pyelonephritis
• Acute kidney injury (AKI stage ≥ 1)
• Other individuals especially in need of protection (according to the Swiss Academy of Medical Sciences)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

Bern, CH-3010, Switzerland

Location

Related Publications (5)

• Bosniak MA. Diagnosis and management of patients with complicated cystic lesions of the kidney. AJR Am J Roentgenol. 1997 Sep;169(3):819-21. doi: 10.2214/ajr.169.3.9275903. No abstract available.

  PMID: 9275903 BACKGROUND

• Curry NS, Cochran ST, Bissada NK. Cystic renal masses: accurate Bosniak classification requires adequate renal CT. AJR Am J Roentgenol. 2000 Aug;175(2):339-42. doi: 10.2214/ajr.175.2.1750339.

  PMID: 10915671 BACKGROUND

• Balci NC, Semelka RC, Patt RH, Dubois D, Freeman JA, Gomez-Caminero A, Woosley JT. Complex renal cysts: findings on MR imaging. AJR Am J Roentgenol. 1999 Jun;172(6):1495-500. doi: 10.2214/ajr.172.6.10350279.

  PMID: 10350279 BACKGROUND

• Nicolau C, Bunesch L, Sebastia C. Renal complex cysts in adults: contrast-enhanced ultrasound. Abdom Imaging. 2011 Dec;36(6):742-52. doi: 10.1007/s00261-011-9727-8.

  PMID: 21461960 BACKGROUND

• Schneider AG, Hofmann L, Wuerzner G, Glatz N, Maillard M, Meuwly JY, Eggimann P, Burnier M, Vogt B. Renal perfusion evaluation with contrast-enhanced ultrasonography. Nephrol Dial Transplant. 2012 Feb;27(2):674-81. doi: 10.1093/ndt/gfr345. Epub 2011 Jun 20.

  PMID: 21690200 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases, Cystic; Kidney Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Spyridon Arampatzis, MD

  Dep. of Nephrology, Hypertension and Clinical Pharmacology, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: February 25, 2015
• Study Start: August 19, 2014
• Primary Completion: October 20, 2017
• Study Completion: June 30, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CH (1)