Liver Metastasis Colon CancerPhase 1PSMANCT06935149
Detecting Colorectal Cancer With Liver Metastatic Lesions Using Novel Precise Imaging Tools
A Phase 1 study testing 18-PSMA in people with Liver Metastasis Colon Cancer, run by Primo Biotechnology Co., Ltd at 1 site in Taiwan.
Trial summary
This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Liver Metastasis Colon Cancer
- What is being tested?
- 18-PSMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2025to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Liver Metastasis Colon Cancer
- Being tested
- 18-PSMA
- Keywords
- Liver metastasis, PSMA, PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-PSMADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PSMA-PET | Experimental | Not described Receives: Drug: 18-PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start31 Oct 2025
- Primary completion30 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Metastasis Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primo Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaoshiung Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Yen-Hsiang Chang, Principal investigator, 886-0975056631
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935149
- Sponsor's protocol ID
- PB012Co
- Acronym
- PSMA
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Liver Metastatic Lesions in Patients of Colorectal Cancer With Novel Precise Imaging Tools
- ClinicalTrials.gov ID
- NCT06935149
- Acronym / sponsor ID
- PSMA / PB012Co
- Conditions
- Liver Metastasis Colon Cancer
- Keywords
- Liver metastasis, PSMA, PET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Primo Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kaoshiung Chang Gung Memorial Hospital
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will demonstrate the diagnostic utility of PSMA PET among patients with CRC with liver metastasis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA-PET | Experimental | Drug: 18-PSMA |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18-PSMAIntravenous 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. | Drug | PSMA-PET |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Hsiang Chang principal investigator
886-0975056631
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18-PSMA in people with Liver Metastasis Colon Cancer, run by Primo Biotechnology Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.