FAST HOC-FAPI PET for Staging of High-Grade Serous Ovarian Cancer .
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- FAPI positivity
研究概览
简要总结
The investigator will use a technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data are gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.
The purpose of this study is to find out if the use of 68Ga-PNT6555 (FAPI) PET-CT will improve the assessment of disease extent as compared to routine CT scans.
详细描述
The investigator will use a technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data are gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.
The purpose of this study is to find out if the use of 68Ga-PNT6555 (FAPI) PET-CT will improve the assessment of disease extent as compared to routine CT scans. The radiopharmaceutical ("radiotracer") 68Ga-PNT6555 (FAPI) is experimental. Experimental means Health Canada has not approved the sale or use of 68Ga-PNT6555 (FAPI), but they have approved its use in this research study.
About 30 patients will take part in this study, and estimate it will take up to 3 years to complete the study enrollment.
Our primary goal is to determine if high-grade epithelial ovarian cancers have a strong affinity for 68Ga-PNT6555, which is a Fibroblast activation protein inhibitor also known as FAPI.
Our secondary objectives: Compare Positron Emission Tomography (PET) scan to CT (computerized tomography) and surgical findings, check FAPI uptake after chemotherapy and assess 68Ga-PNT6555 safety.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for inclusion in this study if they meet the following criteria:
- •Age ≥18 years.
- •Cytological or histological diagnosis of HGSOC, or clinical suspicion of HGSOC based on symptoms, physical exam, tumour markers, and imaging findings.
- •Clinical stage III or IV, being considered for PCS or NACT.
- •Contrast-enhanced CT abdomen and pelvis within 6 weeks of PET (prior to enrolment).
排除标准
- •Patients will be ineligible to participate in this study if they meet any of the following criteria:
- •Inability to provide informed consent.
- •Contraindications for PET examination as per institutional safety guidelines, including but not limited to pregnancy, or inability to lie still for PET examination.
- •Evidence of the following epithelial ovarian cancer histological subtypes: Mucinous, low-grade serous, low-grade endometrioid, and low-malignant potential tumours.
- •Non-ovarian advanced gynecological malignancy
结局指标
主要结局
FAPI positivity
时间窗: through study completion, an average of 1 year
A lesion will be considered abnormal when focal tracer accumulation is greater than background activity and cannot be attributed to a physiological or benign entity.FAPI tumour volumes will be correlated with clinical outcome measures including: 1. Achievement of optimal or complete cytoreduction; 2. Progression-free survival (PFS); 3. Overall survival (OS).
Quantitative parameters
时间窗: through study completion, an average of 1 year
Comparison of tracer uptake (SUVmax/mean) in a lesion to reference tissues (blood pool, liver); calculation of ratio of lesion SUV/ reference tissues.
次要结局
- Modality performance measures (CT vs PET)(through study completion, an average of 1 year)
- Frequency of AE's(through study completion, an average of 1 year)