Status:
NOT_YET_RECRUITING
Detecting Colorectal Cancer With Liver Metastatic Lesions Using Novel Precise Imaging Tools
Lead Sponsor:
Primo Biotechnology Co., Ltd
Collaborating Sponsors:
Kaohsiung Chang Gung Memorial Hospital,Taiwan
Conditions:
Liver Metastasis Colon Cancer
Eligibility:
All Genders
20-100 years
Phase:
PHASE1
Brief Summary
This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- 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.
- WHO performance status ≦ 2 points
- 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.
- 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.
- The participants suffered acute kidney injury within 6 months.
- The participants suffered trauma or fracture.
- The participants are allergic to any radiopharmaceutical or imaging agent.
- The participants are history of claustrophobia or are inability to remain quiet during the examination.
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06935149
Start Date
May 1 2025
End Date
December 31 2025
Last Update
April 24 2025
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