About this trial
This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participants can voluntarily sign informed consent forms
The participants are male/female over 20 years old.
The participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer
The participants are confirmed liver metastasis by CT, abdominal ultrasound, MRI, and FDG PET/CT within 30 days before receiving PSMA-PET/CT.
Disqualifiers
The colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver.
The colorectal cancer participants have undergone any treate after diagnosis of liver metastasis.
The participants have suffered from liver dysfunction such as AST/ALT ratio >2、total bilirubin >1.5 mg/dL within 6 months.
The participants suffered stage IV chronic kidney disease (eGFR<30 mL/min/1.73 m2) within 6 months.
Trial design
Single group
Treatments tested in this trial
18-PSMA
DrugIntravenous push 4 MBq/kg per patient (for a 70 kg patient, 280 MBq of \[18F\]FPSMA needs to be intravenously injected), and the maximum dose cannot exceed 400 MBq. After the injection of \[18F\]FPSMA, intravenous flushing was performed with 20 ml of normal saline.
Treatment groups
Trial outcomes
Primary outcomes
PSMA positive detection rate is defined as the rate that is detected positive lesion at the same location/region between [18F]FPSMA-1007 PET/CT (60- minute images) and reference standard.
Locations
Sponsors and contacts
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Primo Biotechnology Co., Ltd
Lead sponsor
Kaohsiung Chang Gung Memorial Hospital,Taiwan
Collaborator
This trial is not recruiting at the moment. You can still explore other options: