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

NCT06935149 | Not Yet Recruiting Phase 1

• 1 other identifier: PB012Co
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Liver Metastasis Colon Cancer

Keywords

Liver metastasis; PSMA; PET

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PSMA-PET

EXPERIMENTAL

Drug: 18-PSMA

Interventions

18-PSMA DRUG

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.

PSMA-PET

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Primo Biotechnology Co., Ltd: lead
• Kaohsiung Chang Gung Memorial Hospital,Taiwan: collaborator

MeSH Terms

Interventions

PSMA-BCH

Central Study Contacts

Yen-Hsiang Chang

CONTACT

886-0975056631; changyh@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share