Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis
- Conditions
- Invasive Fungal DiseaseChronic Disseminated CandidiasisHematopoietic Stem Cell TransplantationNeutropeniaHematological Malignancies
- Interventions
- Device: 18F-FDG PET Scan
- Registration Number
- NCT01916057
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.
- Detailed Description
Chronic disseminated candidiasis, often referred to as hepatosplenic candidiasis (HSC), is an infection due to Candida spp. that mainly involves the liver and spleen. HSC occurs mostly in patients with profound and prolonged neutropenia, which is more often seen in patients with hematologic malignancies. Despite an appropriate antifungal prophylaxis, the incidence of HSC in France might be closed to 5% in patients suffering from acute leukemia. Early and adequate diagnosis and treatment of HSC are crucial, as treatment delays can negatively affect the prognosis of the underlying condition. Current guidelines recommend a 6-month duration treatment. Prolonged treatments up to 6 months are frequent, leading to antifungal toxicity and cost increase. Preliminary study by our team has already assessed F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) as a diagnostic tool for HSC. 18F-FDG PET scan could be helpful in the diagnosis, follow-up and therapy strategy of HSC, helping to stop antifungal treatment. Other molecular, immunological and serological tools have to be developed in order to avoid hepatic biopsies. Actually, mycological evidence of infection is found in only 20% of the cases. The pathogenesis of HSC is also not well understood, but it is believed that it may be due to an unbalanced adaptive immune response that leads to an exacerbated inflammatory reaction, resulting in an Immune Reconstitution Inflammatory Syndrome (IRIS). In that context, a better understanding of the disease pathophysiology and of the potential genetic susceptibility could have an impact on therapy strategy. For example, new approaches such as the use of adjuvant high-dose corticosteroids have been shown beneficial. This study is the first step to improve HSC diagnosis and therapy strategy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-FDG PET Scan 18F-FDG PET Scan 18F-FDG PET Scan at Day 0 and M3
- Primary Outcome Measures
Name Time Method Global response to therapy at month 3 Clinical assessment (no fever) and PET scan assessment (intensity of liver and/or spleen lesions)
- Secondary Outcome Measures
Name Time Method 18F-FDG PET scan and RMI usefulness in initial diagnosis at month 3 Comparison between Day 0 and Month 3 exams
Genetic susceptibility at day 0 Search for susceptibility genes to candidiasis in comparison with controls
Serological and molecular mycological tools assessment at Month 6 Measurement of beta-1,3-D-glucans, mannan/anti-mannan, anti-Saccharomyces cerevisiae antibodies in comparison with controls.
Assessment of a new real-time PCR on serum and hepatic tissueInflammatory cells and mediators at month 6 Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls
Trial Locations
- Locations (1)
Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades,
🇫🇷Paris, France