FDG-PET study for pulmonary MAC and CPA

JRCT ID: jRCTs071190035

Registered date:15/11/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pulmonary MAC infection, chronic pulmonary aspergillosis
• Date of first enrollment: 19/06/2020
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Twice FDG-PET/CT examinations (before treatment and after treatment initiation) for pulmonary MAC infection and CPA.

Outcome(s)

Primary Outcome

1. Acid-fast bacilli culture examination after 52 weeks of treatment initiation(pulmonary MAC infection)
2. Comprehensive treatment efficacy assessment after 24 weeks of treatment initiation (CPA)
3. FDG-PET/CT SUV max, SUV peak, Target/Background ratio (TBR), Metabolic Tumor Volume (MTV), Total Lesion Glycolysis (TLG)

Secondary Outcome

1. Treatment efficacy after 4 and 24 weeks of treatment initiation (pulmonary MAC infection)
2. Comprehensive treatment efficacy assessment after 4 and 12 weeks of treatment initiation (CPA)
3. Restart of antimicrobial agents from 52 to 76 weeks after the first treatment start (pulmonary MAC infection)
4. Restart of antimicrobial agents from 24 to 48 weeks after the first treatment start (CPA)
5. COPD assessment test, Body weight, Serum albumin, Sputum culture examination and drug susceptibility of MAC or Aspergillus species
6. Adverse events of FDG-PET/CT examination

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients diagnosed with pulmonary Mycobacterium avium complex (MAC) infection based on American Thoracic Society / American Society of Infectious Diseases Guideline 2017, or patients diagnosed with chronic pulmonary aspergillosis (CPA) based on the European Society of Clinical Microbiology / European Society of Medical Mycology / European Respiratory Society 2017.
(2) Patients who have not been treated with antimicrobial agents against pulmonary MAC infection or CPA .
(3) Patients who are older than 20 at the time of informed consent.
(4) Patients with written informed consent after receiving sufficient information.

Exclude criteria

(1) Diabetic patients with poor control (more than 200 mg/dL of fasting blood glucose level).
(2) Patients with cystic fibrosis.
(3) Patients with active respiratory infection except for pulmonary MAC infection or CPA.
(4) Patients with pulmonary MAC infection and CPA.
(5) Patients with lung cancer at the time of informed consent.
(6) Women who are currently pregnant or may be pregnant.
(7) Patient who are judged unsuitable for this study by the investigator.

Related Information

• Primary Sponsor: Takazono Takahiro
• Source(s) of Monetary Support: Non profit organization aimed to support community medicine research in NAGASAKI