CompletedNot Applicable

PET/CT Guided Antifungal Stewardship in Invasive Pulmonary Aspergillosis

France51 participantsStarted 2017-06-02

Plain-language summary

OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary aspergillosis (IPA) could occur earlier than that of conventional imaging. This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6. The latter response will be correlated with the kinetics of selected biomarkers including antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host response markers in addition to the conventional imaging tools obtained at weeks 6 and 12.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients ≥18 years-old * Patient with hematological malignancy * Proven or probable invasive pulmonary aspergillosis according to EORTC/MSG modified criteria * Inclusion ≤ 4 days (≤ 5 days in case of week end) after IPA diagnosis * Possibility to perform 18F-FDG-PET/CT scanner within the 7 subsequent days following diagnosis * Informed consent form signed * Affiliation to French social insurance Exclusion Criteria: * Pregnancy or breastfeeding women * Life expectancy \< 3 months * Fungal or mycobacterial lung co infection at time of IPA diagnosis * Haematological malignancy with lung location * Proven or probable mold infection in 6 previous months * Disseminated aspergillosis (lung and sinus aspergillosis can be included)

What they're measuring

Response rate according to 18F-FDG-PET/CT (PET/CT response)

Timeframe: 6 weeks

Trial details

NCT IDNCT02955966

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-02