CancerFAPI-VTCNCT05485792
18F-FAPI and 18F-FDG PET/CT in Patients With Various Types of Cancer
A study testing 18F-FAPI PET/CT and 18F-FDG PET/CT in people with Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Trial summary
FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- 18F-FAPI PET/CT and 18F-FDG PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 30 Dec 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (aged 18 years or order);
- patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include CT, MRI and pathology report);
- patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans;
- patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Who cannot join
- patients with non-malignant lesions;
- patients with pregnancy;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Study on Comparison 18F-FAPI and 18F-FDG PET/CT in the Evaluation of Patients With Various Types of Cancer
FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.
Read the detailed description
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fibroblast membranes. FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for the visualization of CAFs. CAFs are crucial component of tumor stroma, promote the growth of cancer cells and are associated with poor prognosis. Currently, Gallium 68 (68Ga)-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors, including lung cancer, gastric carcinomas, peritoneal carcinomas. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.
- Conditions
- Cancer
- Being tested
- 18F-FAPI PET/CT and 18F-FDG PET/CT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAPI PET/CT and 18F-FDG PET/CTDiagnostic test
Each subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week
| Study group | Role | What they receive |
|---|---|---|
| 18F-FAPI PET/CT | Experimental | Each subject undergone both 18F-FDG and 68Ga-FAPI PET/CT scans within 2 week Receives: Diagnostic Test: 18F-FAPI PET/CT and 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum standardized uptake value (SUVmax)
The SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT
Measured: 30 days
Secondary outcomes (1)
The target-to-background ratio (TBR)
The target-to-background ratio (TBR) was calculated by dividing the SUVmax of the lesion by the SUVmax of soft tissue background
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- Subjects with various types of cancer undergo contemporaneous 18F-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rusen Zhang, MD, Study director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485792
- Sponsor's protocol ID
- FAPI-malignancy
- Acronym
- FAPI-VTC
- Status last verified
- Jul 2022
- First submitted
- 1 Aug 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liang J, Weng S, Zhang J, Jiang S, Li W, Li S, Rong J, Liu H, Chen H, Liu Z, Peng H, Yan S, Zhang R, Liang SH, Zhang L. Diagnostic performance of [18F]FAPI-04 PET/CT in suspected recurrent hepatocellular carcinoma: prospective comparison with contrast-enhanced CT/MRI. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):3951-3962. doi: 10.1007/s00259-025-07273-4. Epub 2025 Apr 15.
PubMed 40232335Liang Z, Peng H, Li W, Liu Z. Head-to-head study of [18F]FAPI-04 PET/CT and [18F]FDG PET/CT for non-invasive assessment of liver cancer and its immunohistochemical markers. BMC Cancer. 2024 Nov 11;24(1):1378. doi: 10.1186/s12885-024-13153-1.
PubMed 39528951Liang J, Jiang S, Song J, Chen D, Weng S, Li S, Peng H, Liu Z, Zhang J, Chen Y, Rao S, Chen H, Zhang R, Liu H, Zhang L. Role of [18F]FAPI-04 in staging and therapeutic management of intrahepatic cholangiocarcinoma: prospective comparison with [18F]FDG PET/CT. EJNMMI Res. 2024 Sep 11;14(1):81. doi: 10.1186/s13550-024-01145-y.
PubMed 39256297Zhang J, Jiang S, Li M, Xue H, Zhong X, Li S, Peng H, Liang J, Liu Z, Rao S, Chen H, Cao Z, Gong Y, Chen G, Zhang R, Zhang L. Head-to-head comparison of 18F-FAPI and 18F-FDG PET/CT in staging and therapeutic management of hepatocellular carcinoma. Cancer Imaging. 2023 Oct 30;23(1):106. doi: 10.1186/s40644-023-00626-y.
PubMed 37899452
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Comparison 18F-FAPI and 18F-FDG PET/CT in the Evaluation of Patients With Various Types of Cancer
- ClinicalTrials.gov ID
- NCT05485792
- Acronym / sponsor ID
- FAPI-VTC / FAPI-malignancy
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 3 Aug 2022 (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.
FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.
Detailed description
Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fibroblast membranes. FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for the visualization of CAFs. CAFs are crucial component of tumor stroma, promote the growth of cancer cells and are associated with poor prognosis. Currently, Gallium 68 (68Ga)-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors, including lung cancer, gastric carcinomas, peritoneal carcinomas. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects with various types of cancer undergo contemporaneous 18F-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection.
| Arm | Type | Receives |
|---|---|---|
| 18F-FAPI PET/CT | Experimental | Diagnostic Test: 18F-FAPI PET/CT and 18F-FDG PET/CTEach subject undergone both 18F-FDG and 68Ga-FAPI PET/CT scans within 2 week |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients (aged 18 years or order);
- patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include CT, MRI and pathology report);
- patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans;
- patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Key exclusion criteria (3 listed)
- patients with non-malignant lesions;
- patients with pregnancy;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
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 |
|---|---|---|
| 18F-FAPI PET/CT and 18F-FDG PET/CTEach subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week | Diagnostic test | 18F-FAPI PET/CT |
Primary outcome
Maximum standardized uptake value (SUVmax)
Time frame: 30 days
The SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT
1 secondary outcome
The target-to-background ratio (TBR)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 40232335Liang J, Weng S, Zhang J, Jiang S, Li W, Li S, Rong J, Liu H, Chen H, Liu Z, Peng H, Yan S, Zhang R, Liang SH, Zhang L. Diagnostic performance of [18F]FAPI-04 PET/CT in suspected recurrent hepatocellular carcinoma: prospective comparison with contrast-enhanced CT/MRI. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):3951-3962. doi: 10.1007/s00259-025-07273-4. Epub 2025 Apr 15.
- Derived from this study: PubMed 39528951Liang Z, Peng H, Li W, Liu Z. Head-to-head study of [18F]FAPI-04 PET/CT and [18F]FDG PET/CT for non-invasive assessment of liver cancer and its immunohistochemical markers. BMC Cancer. 2024 Nov 11;24(1):1378. doi: 10.1186/s12885-024-13153-1.
- Derived from this study: PubMed 39256297Liang J, Jiang S, Song J, Chen D, Weng S, Li S, Peng H, Liu Z, Zhang J, Chen Y, Rao S, Chen H, Zhang R, Liu H, Zhang L. Role of [18F]FAPI-04 in staging and therapeutic management of intrahepatic cholangiocarcinoma: prospective comparison with [18F]FDG PET/CT. EJNMMI Res. 2024 Sep 11;14(1):81. doi: 10.1186/s13550-024-01145-y.
- Derived from this study: PubMed 37899452Zhang J, Jiang S, Li M, Xue H, Zhong X, Li S, Peng H, Liang J, Liu Z, Rao S, Chen H, Cao Z, Gong Y, Chen G, Zhang R, Zhang L. Head-to-head comparison of 18F-FAPI and 18F-FDG PET/CT in staging and therapeutic management of hepatocellular carcinoma. Cancer Imaging. 2023 Oct 30;23(1):106. doi: 10.1186/s40644-023-00626-y.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Rusen Zhang, MD study director
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FAPI PET/CT and 18F-FDG PET/CT in people with Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
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 4 inclusion and 3 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Rusen Zhang, MD (0086-13642328295, zhangrusen2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum standardized uptake value (SUVmax) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485792, which also lists 4 linked publications.
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 3 Aug 2022.