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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20-100
SponsorPrimo Biotechnology Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: PSMA-PETExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Primo Biotechnology Co., Ltd

Lead sponsor

Kaohsiung Chang Gung Memorial Hospital,Taiwan

Collaborator

This trial is not recruiting at the moment. You can still explore other options: