Invasive Fungal DiseaseCANHPARINCT01916057
Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis
A study testing 18F-FDG PET Scan in people with Invasive Fungal Disease and Chronic Disseminated Candidiasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Invasive Fungal Disease, Chronic Disseminated Candidiasis, Hematological Malignancies
- What is being tested?
- 18F-FDG PET Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2013to 28 Feb 2018
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Patients' inclusion criteria:
- Adults aged ≥18 years-old
- Hospitalized for hematological malignancy or hematopoietic stem cell transplantation
- Recent (>2months), prolonged (>10 days), profound (>100 PMN/mm3), feverish neutropenia
- Suspected hepatosplenic candidiasis (typical small nodular lesions on abdominal RMI or CT)
Patients' exclusion criteria:
- hepatosplenic lesions of other proven origin
Patients' non-inclusion criteria:
- Life expectancy >3 months
- Pregnancy
- HIV infection
- Hepatic biopsy within 3 weeks before 18F-FDG PET scan
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades,
Paris, 75015
About this study
Official title: Multicenter Prospective Pilot Study Investigating Pathophysiology, Diagnostic and Therapeutic Strategies of Hepatosplenic Candidiasis
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.
Read the 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.
- Conditions
- Invasive Fungal Disease, Chronic Disseminated Candidiasis, Hematological Malignancies, Hematopoietic Stem Cell Transplantation, Neutropenia
- Being tested
- 18F-FDG PET Scan
- Keywords
- Positron-Emission Tomography Scan, Fluorodeoxyglucose F18, Magnetic Resonance Imaging, Enzyme-Linked Immunospot Assay, Immune Reconstitution Inflammatory Syndrome, Real-Time Polymerase Chain Reaction, beta-1,3-D-glucan, Candida spp., Genetic Susceptibility, Genotype
- Medical subject headings
- Invasive Fungal Infections, Hematologic Neoplasms, Neutropenia, Immune Reconstitution Inflammatory Syndrome, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET ScanDevice
to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG PET Scan | Experimental | 18F-FDG PET Scan at Day 0 and M3 Receives: Device: 18F-FDG PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global response to therapy
Clinical assessment (no fever) and PET scan assessment (intensity of liver and/or spleen lesions)
Measured: at month 3
Secondary outcomes (8)
18F-FDG PET scan and RMI usefulness in initial diagnosis
Comparison between Day 0 and Month 3 exams
Measured: at month 3
Serological and molecular mycological tools assessment
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 tissue
Measured: at day 0
Serological and molecular mycological tools assessment
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 tissue
Measured: at Month 3
Serological and molecular mycological tools assessment
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 tissue
Measured: at Month 6
Inflammatory cells and mediators
Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls
Measured: at day 0
Inflammatory cells and mediators
Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls
Measured: at month 3
Inflammatory cells and mediators
Measurement of cytokines and lymphocytes populations on serum and hepatic tissue in comparison with controls
Measured: at month 6
Genetic susceptibility
Search for susceptibility genes to candidiasis in comparison with controls
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start19 Nov 2013
- Primary completion1 Jun 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Invasive Fungal DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, University Hospital, Lille, Institut Pasteur, Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916057
- Sponsor's protocol ID
- P120115
- Other IDs
- AOM12047
- Acronym
- CANHPARI
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2013
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rammaert B, Maunoury C, Rabeony T, Correas JM, Elie C, Alfandari S, Berger P, Rubio MT, Braun T, Bakouboula P, Candon S, Montravers F, Lortholary O. Does 18F-FDG PET/CT add value to conventional imaging in clinical assessment of chronic disseminated candidiasis? Front Med (Lausanne). 2022 Dec 20;9:1026067. doi: 10.3389/fmed.2022.1026067. eCollection 2022.
PubMed 36606049Candon S, Rammaert B, Foray AP, Moreira B, Gallego Hernanz MP, Chatenoud L, Lortholary O. Chronic Disseminated Candidiasis During Hematological Malignancies: An Immune Reconstitution Inflammatory Syndrome With Expansion of Pathogen-Specific T Helper Type 1 Cells. J Infect Dis. 2020 May 11;221(11):1907-1916. doi: 10.1093/infdis/jiz688.
PubMed 31879764