Clinical trial · Interventional
PET/CT Guided Antifungal Stewardship in Invasive Pulmonary Aspergillosis
NCT02955966CI-TRIAL-00097598OPTIFILcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aspergillosis and Haematological Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection | Biological | — | UNRESOLVED |
| imaging 18F-FDG-PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient with invasive pulmonary aspergillosis
- description
- Blood collection and imaging 18F-FDG-PET/CT
- interventionNames
- Device: imaging 18F-FDG-PET/CT
- Biological: Blood collection
Primary outcomes (1)
- measure
- Response rate according to 18F-FDG-PET/CT (PET/CT response)
- timeFrame
- 6 weeks
Secondary outcomes (10)
- measure
- Response rate according to EORTC/MSG criteria (Segal response).
- timeFrame
- 6 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (11)
- BACKGROUNDLortholary O, Gangneux JP, Sitbon K, Lebeau B, de Monbrison F, Le Strat Y, Coignard B, Dromer F, Bretagne S; French Mycosis Study Group. Epidemiological trends in invasive aspergillosis in France: the SAIF network (2005-2007). Clin Microbiol Infect. 2011 Dec;17(12):1882-9. doi: 10.1111/j.1469-0691.2011.03548.x. Epub 2011 Jun 10. PMID 21668573
- BACKGROUNDBitar D, Lortholary O, Le Strat Y, Nicolau J, Coignard B, Tattevin P, Che D, Dromer F. Population-based analysis of invasive fungal infections, France, 2001-2010. Emerg Infect Dis. 2014 Jul;20(7):1149-55. doi: 10.3201/eid2007.140087. PMID 24960557
- BACKGROUNDHerbrecht R, Caillot D, Cordonnier C, Auvrignon A, Thiebaut A, Brethon B, Michallet M, Mahlaoui N, Bertrand Y, Preziosi P, Ruiz F, Gorin NC, Gangneux JP. Indications and outcomes of antifungal therapy in French patients with haematological conditions or recipients of haematopoietic stem cell transplantation. J Antimicrob Chemother. 2012 Nov;67(11):2731-8. doi: 10.1093/jac/dks266. Epub 2012 Jul 31. PMID 22850692
- BACKGROUNDBaxter CG, Marshall A, Roberts M, Felton TW, Denning DW. Peripheral neuropathy in patients on long-term triazole antifungal therapy. J Antimicrob Chemother. 2011 Sep;66(9):2136-9. doi: 10.1093/jac/dkr233. Epub 2011 Jun 17. PMID 21685202
- BACKGROUNDEpaulard O, Villier C, Ravaud P, Chosidow O, Blanche S, Mamzer-Bruneel MF, Thiebaut A, Leccia MT, Lortholary O. A multistep voriconazole-related phototoxic pathway may lead to skin carcinoma: results from a French nationwide study. Clin Infect Dis. 2013 Dec;57(12):e182-8. doi: 10.1093/cid/cit600. Epub 2013 Sep 17. PMID 24046296
- BACKGROUNDTedja R, El-Sherief A, Olbrych T, Gordon S. Multifocal periostitis as a complication of chronic use of voriconazole in a lung transplant recipient. Transpl Infect Dis. 2013 Aug;15(4):424-9. doi: 10.1111/tid.12088. Epub 2013 May 13. PMID 23663268