Detecting Colorectal Cancer With Liver Metastatic Lesions... | NCT06935149

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

NCT06935149

Sponsor

Primo Biotechnology Co., Ltd

Status

Completed

Last Update Posted

Jul 6, 2026Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Liver Metastasis Colon Cancer

Interventions

18-PSMA

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2025Actual

Primary Completion Date

Apr 30, 2026Actual

Completion Date

Jun 30, 2026Actual

First Submitted Date

Apr 11, 2025

First Submission Date that Met QC Criteria

Apr 11, 2025

First Posted Date

Apr 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Name	Class
Kaoshiung Chang Gung Memorial Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSMA-PET	Experimental		Drug: 18-PSMA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	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.		14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yen-Hsiang Chang	886-0975056631	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Chang Gung Memorial Hospital		Kaohsiung City		833401	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided