Detecting Colorectal Cancer With Liver Metastatic Lesions Using Novel Precise Imaging Tools (PSMA)

Primo Biotechnology

Status and phase: Not yet enrolling; Phase 1

Conditions: Liver Metastasis Colon Cancer

Treatments: Drug: 18-PSMA

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06935149

PB012Co

Details and patient eligibility

About

This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.

Enrollment: 5 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

PSMA-PET

Experimental group

Treatment:

Drug: 18-PSMA