Cutting Edge Imaging for Earlier Pancreatic Cancer Diagnosis: Evaluation of Positron Emission Tomography (PET) With the Fibroblast Activation Protein Inhibitor (FAPI)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- EFS: Event Free Survival
研究概览
简要总结
Assessment of the relevance of a new medical imaging test, FAPI PET, which could detect progression or relapse earlier than other tests currently available. Ultimately, it could enable early forms of pancreatic cancer to be detected and used for screening.
In addition to the usual examinations prescribed, FAPI PET scans will be repeated at several points in the treatment process.
All study patients must first have been included in the Homing cohort (NCT 04363983, APHP promotion). Clinical characteristics, judgement criteria and results of biological or imaging examinations carried out as part of this cohort will be shared.
Patient follow-up and participation in the study ends when conventional imaging (CT and MRI) shows disease progression, relapse or death.
详细描述
Development of imaging biomarkers derived from FAPI PET among patients with a newly-diagnosed resectable or locally advanced PDAC, in order (i) to detect a metastatic disease at inclusion and (ii) to detect disease recurrence after surgical resection with a higher sensitivity than the standard evaluation.
Prospective cohort involving repeated medical imaging with a new radiotracer (FAPI). Patients meeting inclusion criteria will be stratified according to the disease staging: resectable, borderline or locally advanced PDAC.
At inclusion after confirmed non-metastatic PDAC diagnosis, all patients will have:
Baseline exams (V1) with 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT (within 1 month after inclusion in HoMING study) for all enrolled patients with resectable, borderline or locally advanced PDAC at inclusion.
Second pre-operative exams (V1b) with 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT exams only for patients who received neoadjuvant/induction treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cyto/histologically proven PDAC
- •Non-metastatic proven PDAC on recent (< 1 month) CT-scan and MRI
- •Concomitant enrollment in the HoMING prospective cohort (Sponsor: AP-HP, NCT04363983)
- •Age > 18 years old
- •Affiliation to a social security scheme
- •Signed informed consent
排除标准
- •Protected adults (guardianship, curatorship or safeguarding justice)
- •Pregnant or breastfeeding woman
- •Women of childbearing potential not using one highly effective method of contraception
研究组 & 干预措施
Prospective cohort involving repeated medical imaging with a new radiotracer (68Ga-FAPI-46)
All patients of this study must have been previously enrolled in the HoMING cohort (NCT 04363983, sponsor APHP).
干预措施: 68Ga-FAPI-46 for PET / CT scan (Drug)
结局指标
主要结局
EFS: Event Free Survival
时间窗: 12 months
Time from diagnosis to disease progression, recurrence or death (EFS: Event Free Survival). Radiomic features from the initial FAPI evaluation will be analyzed using univariable and multivariable survival models to detect and quantify statistical associations between feature values and EFS. A multivariable model will be proposed and will serve as basis for the estimation of screening sensitivity.
次要结局
- Adverse Event during 68Ga-FAPI-46 PET/CT exams(12 months)
- Evaluation of the tumor burden 68Ga-FAPI-46 PET/CT versus 18F-FDG PET/CT(12 months)