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 range

18 Years

Sex

ALL

See this in plain English?

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Aspergillosis and Haematological Malignancy trials