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

April 18, 2025 updated by: Primo Biotechnology Co., Ltd

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMA-PET
Drug: 18-PSMA
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Primo Biotechnology Co., Ltd

Collaborators

Kaohsiung Chang Gung Memorial Hospital,Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB012Co

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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