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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Liver Metastasis Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PSMA-PET

Group Type EXPERIMENTAL

18-PSMA

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No