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NCT02371551
Evaluation of Complex Renal Cyst With CEUS/Functional MRI Versus CT
trial testing Blood/urine sampling in Cystic Renal Diseases in 52 participants. Completed in 30 June 2018.
20 October 2017
Quick facts
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 52 |
| Start date | 19 August 2014 |
| Primary completion | 20 October 2017 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Blood/urine sampling
- Conventional routine CT examination
- Contrast-enhanced renal ultrasonography (CEUS)
- Functional MRI
Conditions studied
- Cystic Renal Diseases — all drugs for Cystic Renal Diseases →
- Kidney Neoplasms — all drugs for Kidney Neoplasms →
Sponsor
Insel Gruppe AG, University Hospital Bern
Who can join
Adults 18 to 99, any sex, with Cystic Renal Diseases or Kidney Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02371551
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02371551 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern
- Last refreshed: 28 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02371551.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing