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临床试验/NCT05518903
NCT05518903招募中2 期

Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
Mayo Clinic
入组人数
130
试验地点
1
主要终点
Relationship between 68Ga-FAPI-46 PET metrics and staging examinations in PDA

研究概览

简要总结

This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts (CAFs) in patients with pancreatic ductal adenocarcinoma (PDA) that has not spread to other parts of the body (localized). CAFs are a type of connective tissue cell that are found within or near cancerous tissue. Many CAFs express a protein called fibroblast activation protein (FAP) that are not found on healthy cells in large amounts. 68Ga-FAPI-46 is a radioactive chemical compound designed to circulate through the body and attach itself to FAP on PDA cells. A PET/CT scan is then used to detect the location of FAP lesions. PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional (3-D) views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.

详细描述

PRIMARY OBJECTIVES:

I. To determine the sensitivity and specificity of gallium Ga 68 FAPi-46 (68Ga-FAPI-46) PET for detection and quantification of cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDA).

II. Construct, test and validate a model of surgical benefit or futility in potentially resectable PDA using 68Ga-FAPI-46 PET biomarkers in combination with other biomarkers of disease.

OUTLINE:

Patients receive 68Ga-FAP-46 intravenously (IV), then allow 60 minutes for 68Ga-FAPI-46 uptake. Patients then undergo PET/CT scans over 30 minutes at baseline (before standard of care [SOC] therapy), up to 2 scans approximately 8 weeks apart (at SOC re-staging visits), and a then a scan within 4 weeks of SOC surgical resection, if applicable.

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

  • •Adults > 18 years (yrs.) with treatment-naive biopsy-proven PDA or with findings diagnostic for PDA on baseline imaging (CT, MRI, or PET)
  • •Localized disease expected to undergo surgical resection following neoadjuvant therapy (NAT)
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • •Ability to provide informed consent

排除标准

  • •Hypersensitivity to any excipients in 68Ga-FAPI-46
  • •Require emergency surgery
  • •Non-PDA histology on biopsy
  • •Histopathologically proven metastatic PDA
  • •Pregnant or lactating women

研究组 & 干预措施

Diagnostic (gallium GA 68 FAPi-46, PET/CT)

Experimental

Patients receive 68Ga-FAP-46 IV, then allow 60 minutes for 68Ga-FAPI-46 uptake. Patients then undergo PET/CT scans over 30 minutes at baseline (before SOC therapy), up to 2 scans approximately 8 weeks apart (at SOC re-staging visits), and a then a scan within 4 weeks of SOC surgical resection, if applicable.

干预措施: Positron Emission Tomography (Procedure)

Diagnostic (gallium GA 68 FAPi-46, PET/CT)

Experimental

Patients receive 68Ga-FAP-46 IV, then allow 60 minutes for 68Ga-FAPI-46 uptake. Patients then undergo PET/CT scans over 30 minutes at baseline (before SOC therapy), up to 2 scans approximately 8 weeks apart (at SOC re-staging visits), and a then a scan within 4 weeks of SOC surgical resection, if applicable.

干预措施: Computed Tomography (Procedure)

Diagnostic (gallium GA 68 FAPi-46, PET/CT)

Experimental

Patients receive 68Ga-FAP-46 IV, then allow 60 minutes for 68Ga-FAPI-46 uptake. Patients then undergo PET/CT scans over 30 minutes at baseline (before SOC therapy), up to 2 scans approximately 8 weeks apart (at SOC re-staging visits), and a then a scan within 4 weeks of SOC surgical resection, if applicable.

干预措施: Gallium Ga 68 FAPi-46 (Drug)

结局指标

主要结局

Relationship between 68Ga-FAPI-46 PET metrics and staging examinations in PDA

时间窗: Up to 5 years

Relationship between 68Ga-FAPI-46 PET metrics and fludeoxyglucose F-18 (FDG) PET staging exam being assessed.

Diagnostic performance of fibroblast-activation-protein-inhibitors (FAPI) positron emission tomography (PET) for detection and quantification of cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDA)

时间窗: Up to 5 years

Using surgical immunohistochemistry (IHC) as gold standard.

Relationship between 68Ga-FAPI-46 PET metrics and Kirsten rat sarcoma (KRAS), circulating tumor deoxyribonucleic acid (ctDNA) biomarkers in PDA

时间窗: Up to 5 years

Relationship between 68Ga-FAPI-46 PET metrics and Kirsten rat sarcoma (KRAS), circulating tumor deoxyribonucleic acid (ctDNA) being assessed.

Relationship between 68Ga-FAPI-46 PET metrics in PDA

时间窗: Up to 5 years

Relationship between 68Ga-FAPI-46 PET metrics assessed

Relationship between 68Ga-FAPI-46 PET metrics and cancer antigen 19-9 (CA19-9) biomarkers in PDA

时间窗: Up to 5 years

Relationship between 68Ga-FAPI-46 PET metrics and cancer antigen 19-9 (CA19-9) being assessed.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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