Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias

Leukemia Clinical Trial

Official title:

Verbesserung Der Radiologischen Diagnose Von Hepatolienaler Candidiasis während Der Therapie Der Leukämie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207843
• Other study ID #: idr-3d-001
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2010
• Last updated: August 18, 2014
• Start date: October 2009
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis.

The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion criteria:

• Chest and Abdomen CT with fungal lesion in patients with leukemia

Exclusion criteria:

• Other liver pathologies

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Candidiasis
• Infection
• Leukemia

Intervention

Behavioral:
• Imaging
CT image validation and lesion measurement, as well as comparison of different CT phases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end-point was IFI according to the EORTC/MSG 2008 definitions and bacteraemia		2 Years	No