Liver Metastasis Colon Cancer
Conditions
Keywords
Liver metastasis, PSMA, PET
Brief summary
This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.
Interventions
DRUG18-PSMA
Intravenous 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.
Sponsors
Primo Biotechnology Co., Ltd
Kaoshiung Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria: 1. The participants can voluntarily sign informed consent forms 2. The participants are male/female over 20 years old. 3. The participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer 4. The participants are confirmed liver metastasis by CT, abdominal ultrasound, MRI, and FDG PET/CT within 30 days before receiving PSMA-PET/CT. 5. WHO performance status ≦ 2 points 6. The participants can lie on table for two hours during PSMA-PET/CT scanning. Main
Exclusion criteria
To improve the accurate interpretation of PMSA-PET imaging and reduce the occurrence of related-drug adverse events, the participants will be excluded by following below criteria. 1. The colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver. 2. The colorectal cancer participants have undergone any treate after diagnosis of liver metastasis. 3. The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months. 4. The participants suffered stage IV chronic kidney disease (eGFR\<30 mL/min/1.73 m2) within 6 months. 5. The participants suffered acute kidney injury within 6 months. 6. The participants suffered trauma or fracture. 7. The participants are allergic to any radiopharmaceutical or imaging agent. 8. The participants are history of claustrophobia or are inability to remain quiet during the examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 14 days |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORYen-Hsiang Chang
886-0975056631
Outcome results
None listed