[68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if [68Ga]Ga-FAPI-46 Total Body PET/CT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that [68Ga]Ga-FAPI-46 Total Body PET/CT can improve staging and treatment evaluation for these patient groups.
The main questions the trial aims to answer are:
- Is [68Ga]Ga-FAPI-46 Total Body PET/CT better at diagnosing metastatic disease in the abdomen compared other imaging modalities?
- Can [68Ga]Ga-FAPI-46 Total Body PET/CT produce accurate images in less than 30 min?
Researchers will examine three different patient groups:
Group A) patients with pancreatic cancer, who are referred to surgery. Group B1) patients with gastroesophageal cancer, who are referred to diagnostic surgery (laparoscopy).
Group B2) a subgroup of gastroesophageal cancer patients, with a specific subtype cancer (signet ring cell carcinoma or poorly cohesive carcinoma), who are referred to oncological treatment.
Participants will undergo:
- One [68Ga]Ga-FAPI Total Body PET/CT before surgery (Group A), or before laparoscopy (group B1), or before oncological treatment (Group B2).
- Participants in group B2 will also undergo a second [68Ga]Ga-FAPI-46 Total Body PET/CT during treatment with chemotherapy.
- All participants will fill out one questionnaire.
- Researchers will follow the patients after the scans for 1 year.
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
- •for group A
- •Male or female, over 18 years old
- •Patients with suspected pancreatic cancer based on morphological findings on standard imaging
- •CT or MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
- •Subjects must have been considered suitable for curative surgery at the time of the referral
- •Subjects must be able to read and understand the patient information in Danish to give informed consent
- •Inclusion criteria for group B1
- •Male or female over 18 years old
- •Histological verified carcinoma from the lower esophagus, GEJ, or stomach
- •Subjects must be considered operable and resectable at the time of referral for MDT
- •Subjects must be able to read and understand the patient information in Danish to give informed consent
- •Inclusion criteria for group B2
- •Male or female over 18 years old
- •Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach
- •Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.
- •Subjects must be able to read and understand the patient information in Danish to give informed consent
排除标准
- •Pregnancy or lactation
- •Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
- •History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46
研究者
Barbara Malene Fischer
Professor, MD, Ph.D.
Rigshospitalet, Denmark