NCT06935149CompletedPhase 1
Detecting Liver Metastatic Lesions in Patients of Colorectal Cancer With Novel Precise Imaging Tools
Primo Biotechnology Co., Ltd1 site in 1 country5 target enrollmentStarted: October 31, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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.
Arms & Interventions
PSMA-PET
Experimental
Intervention: 18-PSMA (Drug)
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.
Time Frame: 14 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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