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OpenTrials
Completed

NCT Number: NCT06935149

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

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

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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Primo Biotechnology Co., Ltd

Industry

Collaborators

  • Kaoshiung Chang Gung Memorial Hospital

Registry information

Official study title

Detecting Liver Metastatic Lesions in Patients of Colorectal Cancer With Novel Precise Imaging Tools

Acronym: PSMA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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