Employment of 68Ga-DOTA-NOC in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
研究概览
简要总结
The investigators aim to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with idiopathic pulmonary fibrosis, in particular in patients with a diagnosis of IPF/UIP (idiopathic pulmonary fibrosis, diagnosed based in the American Thoracic Society and European Respiratory Society criteria) and in forms of NSIP (non-specific interstitial pneumonia). PET/CT imaging data will be compared with HRCT (high-resolution computed tomography) findings to assess disease extension, early disease detection and to non-invasively detect somatostatin receptors expression at lung level in these patients, with potential therapeutic implications.
详细描述
Idiopathic pulmonary fibrosis prognosis remains severe, in particular for IPF, the most common entity. Moreover, current treatment options are largely ineffective and do not change the natural course of the disease. Pre-clinical evidence supports somatostatin receptors expression in the lung of patients with IPF. Recently new PET tracers (Somatostatin analogues labelled with 68Gallium), specifically binding to somatostatin receptors, have been developed and are used in neuroendocrine tumours clinical trials.
Aim of the present study is to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with idiopathic pulmonary fibrosis, in particular in patients with IPF/UIP and in cases with NSIP, that are characterized by a more indolent progression. PET/CT data will be compared with HRCT findings for the early detection of fibrotic areas and to non-invasively assess somatostatin receptors expression at lung level in these patients, with potential therapeutic implications. Moreover, the SUVmax (maximum standardized uptake value) will be analyzed in comparison with disease site and extension on HRCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of IPF and NSIP, based on the American Thoracic Society/European Respiratory Society Consensus Conference
- •age ≥ 18 years
- •males/females
- •signed informed consent
排除标准
- •pregnancy
- •breast feeding
- •healthy volunteers
- •paediatric cases
- •patients in emergency situations
- •patients legally incompetent
- •patients who refuse to sign the informed consent
结局指标
主要结局
Describe pattern of 68Ga-DOTA-NOC uptake in comparison with HRCT findings
时间窗: timeframe between imaging procedures 30 days
次要结局
- 68Ga-DOTA-NOC SUVmax correlation with pulmonary function tests(timeframe between PET/CT and pulmonary fucntion tests 30 days)
研究者
Stefano Fanti
Associate Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna