Liver CancerNCT05806333
[18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
A study testing FAPI PET in people with Liver Cancer, run by Jilin University at 1 site in China.
Trial summary
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- FAPI PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with suspected liver malignant lesions based on traditional diagnostic imaging (CT or MRI or ultrasound) and clinical symptoms;
- patients underwent [18F]FDG PET/CT with negative findings (suspicious primary and/or metastatic lesions were hypo- or isometabolic on [18F]FDG PET/CT);
- patients who agreed to undergo [18F]FAPI PET/CT scans within 1 week.
Who cannot join
- pregnancy;
- age<18 years old;
- patients with chemo/radio/targeted therapy before scanning;
- inability to provide informed consent (signed by participant, parent, or legal representative).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Union Hospital
Changchun, Jilin, 130031
Jun Wei, +8684995117, Weijunsy1949@163.com
About this study
Official title: Diagnostic Performance of [18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. We aim to conduct a prospective study to investigate the diagnostic perfoemance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.
Read the detailed description
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for visualizing CAFs. CAFs are crucial components of the tumor stroma, promote the growth of cancer cells, and are associated with poor prognosis. Currently, 18F-labelled fbroblast activation protein inhibitor 18F-FAPI has shown promising diagnostic value in many types of tumors, especially those in which are not avid for 18F-FDF , and several studies have demonstrated that 18F-FAPI PET/CT is superior to 18F-FDG PET/CT for detecting liver cancer and has lower tracer uptake in normal liver tissue. We aim to conduct a prospective study to investigate the diagnostic performance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.
- Conditions
- Liver Cancer
- Being tested
- FAPI PET
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PETDiagnostic test
Drug: 18F-FAPI 18F-FAPI were injected into the patients before the PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| suspicious focal liver mass without FDG avidity | Experimental | Experimental: 18F-FAPI PET/CT Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer Receives: Diagnostic Test: FAPI PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of FAPI PET
Sensitivity and specificity in detecting liver cancer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Bin, Jilin University
- Investigators
- Bin Ji, Principal investigator, China-Japan Union Hospital, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806333
- Sponsor's protocol ID
- ChinaJapanUH
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of [18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
- ClinicalTrials.gov ID
- NCT05806333
- Acronym / sponsor ID
- ChinaJapanUH
- Conditions
- Liver Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 10 Apr 2023 (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.
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. We aim to conduct a prospective study to investigate the diagnostic perfoemance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.
Detailed description
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for visualizing CAFs. CAFs are crucial components of the tumor stroma, promote the growth of cancer cells, and are associated with poor prognosis. Currently, 18F-labelled fbroblast activation protein inhibitor 18F-FAPI has shown promising diagnostic value in many types of tumors, especially those in which are not avid for 18F-FDF , and several studies have demonstrated that 18F-FAPI PET/CT is superior to 18F-FDG PET/CT for detecting liver cancer and has lower tracer uptake in normal liver tissue. We aim to conduct a prospective study to investigate the diagnostic performance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspicious focal liver mass without FDG avidity | Experimental | Diagnostic Test: FAPI PETExperimental: 18F-FAPI PET/CT Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with suspected liver malignant lesions based on traditional diagnostic imaging (CT or MRI or ultrasound) and clinical symptoms;
- patients underwent [18F]FDG PET/CT with negative findings (suspicious primary and/or metastatic lesions were hypo- or isometabolic on [18F]FDG PET/CT);
- patients who agreed to undergo [18F]FAPI PET/CT scans within 1 week.
Key exclusion criteria (4 listed)
- pregnancy;
- age<18 years old;
- patients with chemo/radio/targeted therapy before scanning;
- inability to provide informed consent (signed by participant, parent, or legal representative).
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 |
|---|---|---|
| FAPI PETDrug: 18F-FAPI 18F-FAPI were injected into the patients before the PET/CT scans | Diagnostic test | suspicious focal liver mass without FDG avidity |
Primary outcome
Diagnostic performance of FAPI PET
Time frame: 1 year
Sensitivity and specificity in detecting liver cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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.
Bin Ji principal investigator
China-Japan Union Hospital, Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAPI PET in people with Liver Cancer, run by Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi Gao [gshi] (+86-84995467, Gaoshi@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of FAPI PET (time frame: 1 year). 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 10 Apr 2023.