Improved baseline staging with 68Ga-FAPI-46 PET in non-small cell lung cancer – a pilot study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determining essential input parameters for the calculation of an appropriate sample size for a future prospective diagnostic study
研究概览
简要总结
The aim of this pilot study is to determine essential input parameters for an adequate sample size calculation for a subsequent diagnostic study that compares the diagnostic accuracy of standard 18F-FDG and brain MRI versus 68Ga -FAPI as PET tracer in patients with newly diagnosed NSCLC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven NSCLC needing 18F-FDG PET/CT for diagnostic workup or biopsy proven NSCLC with 18F-FDG PET/CT already performed
- •ECOG score 0-2
- •Possibility to perform 68Ga-FAPI-46 PET with low dose CT within three weeks after 18F-FDG PET/CT
- •Willing and able to undergo brain MRI if not already performed or scheduled in regular care
- •Provision of signed and dated, written informed consent
排除标准
- •History of lung cancer (treatment) or lung surgery
- •History of other malignancies 5 years prior to the current diagnosis of NSCLC (except carcinoma in situ, melanoma in situ)
- •Chronic inflammatory disease such as rheumatoid arthritis or fibrotic pulmonary conditions
- •Known allergy to MRI contrast agent (i.e gadolinium-based contrast agents) or CT contrast agent (iodinated contrast)
- •Patients with severe renal impairment (eGFR≤30mL/min/1.73m²; the nuclear tracer is primarily excreted through the kidneys. If a patient has severe renal impairment, clearance is reduced, leading to prolonged circulation of the nuclear tracer in the body)
- •Pregnant and lactating women
- •Brain tumor (including meningioma)
- •Contra-indication for MRI such as claustrophobia, pacemaker, clips, severe obesity
结局指标
主要结局
Determining essential input parameters for the calculation of an appropriate sample size for a future prospective diagnostic study
Determining essential input parameters for the calculation of an appropriate sample size for a future prospective diagnostic study
Number and location of metastatic lesions that are detected on the 68Ga-FAPI-46 PET (measure of interest) but not on the 18F-FDG PET in combination with brain MRI (current standard of care)
Number and location of metastatic lesions that are detected on the 68Ga-FAPI-46 PET (measure of interest) but not on the 18F-FDG PET in combination with brain MRI (current standard of care)
Number and location of metastatic lesions detected on the 18F FDG PET in combination with brain MRI (current standard of care) but not on 68Ga-FAPI-46 PET (measure of interest)
Number and location of metastatic lesions detected on the 18F FDG PET in combination with brain MRI (current standard of care) but not on 68Ga-FAPI-46 PET (measure of interest)
次要结局
- Number of patients with brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest)
- In patients with brain metastases: number of brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest)
- Number of patients with at least one 68Ga-FAPI-positive, 18F-FDG-negative lesion for which an additional investigation is clinically necessary
- Number of patients whose disease stage is upstaged based on 68Ga-FAPI-46 PET/CT findings compared to staging based on 18F-FDG PET/CT and brain MRI
研究者
T.J.A van Nijnatten
Scientific
Academisch Ziekenhuis Maastricht