NCT07432633招募中1 期
A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Assess radiation dosimetry of [18F]FPyQCP (Cohort A)
研究概览
简要总结
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
- •Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
- •Eastern Cooperative Oncology Group performance status ≤
- •Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
- •Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [18F]FPyQCP administration.
- •WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study
- •Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease [5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of [18F]FPyQCP administration.
- •Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before [18F]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.
- •Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day
- •Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day
- •[18F]FPyQCP PET/CT imaging should be performed as close to scheduled procedure as clinically feasible.
- •Suspected recurrence after definitive therapy
排除标准
- •Participants administered any radioisotope within 5 physical half-lives prior to [18F]FPyQCP administration.
- •Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [18F]FPyQCP administration.
- •Participants who have recently received any other contrast agent (< 24 hours for intravenous agents and < 5 days for oral agents) before the day of [18F]FPyQCP administration.
- •Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
- •Known hypersensitivity to [18F]FPyQCP or any of its constituents.
- •Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.
- •Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgment, excluding disorders directly related to the index cancer (e.g. tumor-associated pancreatitis or biliary stasis for PDAC).
- •Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
- •Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgment.
- •Significant renal or hepatic impairment.
- •Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [18F]FPyQCP administration.
- •Cohort A Specific Exclusion Criteria:
- •No prior history of any other cancer, unless treated with curative-intent and disease-free for at least 5 years before Visit 1 (at least 1 year before Visit 1 for basal cell carcinoma, localized squamous cell carcinoma of the skin and in situ carcinoma of cervix).
研究组 & 干预措施
[18F]FPyQCP PET/CT
Experimental
Each participant will receive [18F]FPyQCP followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2)
干预措施: [18F]FPyQCP (Drug)
结局指标
主要结局
Assess radiation dosimetry of [18F]FPyQCP (Cohort A)
时间窗: Up to 360 minutes post injection
Whole body effective dose of a single dose of \[18F\]FPyQCP
Assess the diagnostic performance of [18F]FPyQCP in the peritoneum (Cohort B)
时间窗: Until completion of follow-up procedures, up to 42 days post injection
Sensitivity and specificity of \[18F\]FPyQCP PET/CT compared to composite standard of truth
次要结局
- Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts)(From screening until safety follow-up (48 hours post injection))
- Further assess the diagnostic performance of [18F]FPyQCP (Cohort B).(Until completion of follow-up procedures, up to 42 days post injection)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive FunctionNCT07422857JYAMS PET Research & Development Limited316
尚未招募
不适用
HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDGMultiple CancersMultiple Indications CancerFeasibility StudiesNCT07295171British Columbia Cancer Agency27
招募中
3 期
The effect of [18F]F-FAPI PET-CT on management in patients with potentially resectable biliary tract cancers: prospective multicenter study and cost-effectivity analysis.Cholangiocarcinoma2023-507938-24-00Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)81
已完成
不适用
CXCR4 PET/CT for Predicting Outcome in Limited-Stage Small Cell Lung CancerSmall Cell Lung CancerNCT07316309Shandong Cancer Hospital and Institute33
招募中
2 期
mFBG PET-CT for neuroblastoma2022-501694-39-01Princess Maxima Center For Pediatric Oncology58