Fibroblast Activation Protein InhibitorNCT05034146
68Ga-FAPI PET/CT in Malignant Tumors
A study testing 68Ga-FAPI and PET/CT in people with Fibroblast Activation Protein Inhibitor and PET/CT, run by Zhongnan Hospital at 1 site in China.
Trial summary
Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibroblast Activation Protein Inhibitor, PET/CT, Malignant Neoplasm
- What is being tested?
- 68Ga-FAPI and PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in clinical trial and sign an informed consent form Patients with suspected or confirmed malignant tumor
Who cannot join
- Female patients plan to become pregnant within 6 months Pregnant and lactating women Patients are allergic to multiple drugs including test drug Patients have participated in other clinical trials in the past one month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Lei Zheng, +86-27-67812787
Yong He, MD, PhD
About this study
Official title: The Diagnostic Efficiency of 68Ga-FAPI PET/CT in Malignant Tumors
Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.
Read the detailed description
The morbidity and mortality of malignant tumors are increasing. It is one of the major diseases that affect human health. At present, the conventional imaging diagnosis methods of a variety of malignant tumors are mainly CT and MRI based on anatomical imaging. Different from traditional imaging methods to visually display the lesion, nuclear medicine molecular imaging can not only locate the tumor location, but also image the expression and activity of specific molecules and biological processes. This molecular imaging method integrating anatomy and function is a noninvasive imaging to realize the early diagnosis and differential diagnosis, curative effect evaluation and follow-up observation of a variety of tumors. Positron emission tomography/computed tomography (PET/CT) uses specific molecular probes to target tumor. It can provide detailed information about the biochemical changes of tumor tissues at the cellular and molecular levels. It has better sensitivity and specificity than conventional imaging methods. At present, the most commonly used imaging agent in clinic is 18F-fluorodeoxyglucose (18F-FDG). 18F-FDG PET/CT is a valuable imaging modality in the management of patients with malignant tumors, but it is not a specific imaging agent for tumor application. The physiological uptake of gastrointestinal tract, infected tissues, or inflammatory cells can cause high 18F-FDG uptake resulting in a significant increase of the false positive rate; in addition, some tumors including well-differentiated hepatocellular carcinoma, renal cell carcinoma, and gastric signet ring cell carcinoma have low 18F-FDG uptake resulting in a high false negative rate. Therefore, it is very important to develop new molecular probes for targeting tumor.
Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.
- Being tested
- 68Ga-FAPI, 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.
68Ga-FAPIDrug
Also called 68Ga-fibroblast activation protein inhibitor
68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).
PET/CTDevice
Also called positron emission tomography/computed tomography
68Ga-FAPI PET/CT scan were performed 20~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI PET/CT in malignant tumors | Experimental | Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week. Receives: Drug: 68Ga-FAPI; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors
Taking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-FAPI PET/CT in detecting malignant tumor were calculated.
Measured: three years
Secondary outcomes (3)
Prognostic value of FAPI PET parameters in malignant tumors
Correlation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak, measured in the Syngo Workstation (Siemens Healthineers)) and long-term outcomes (e.g., progression-free survival, overall survival).
Measured: From baseline to 1 year post-treatment
FAPI PET for therapeutic response evaluation in malignant tumors
Assessment of FAPI PET parameters, namely SUVmax, SUVmean, SUVpeak, measured in the Syngo Workstation (Siemens Healthineers), for evaluating treatment response in patients with malignant tumors.
Measured: Within 1 week after completion of neoadjuvant or adjuvant therapy
The connection between FAPI PET parameters and histopathological biomarkers.
Analyze the correlation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak, measured in the Syngo Workstation (Siemens Healthineers)) and FAP expression levels (H-score; immunohistochemistry) or immune - related biomarkers, such as PD-L1 expression (Combined Positive Score; Dako 22C3 IHC assay), CD8 expression (H-score; immunohistochemistry), Granzyme B expression (H-score; immunohistochemistry).
Measured: Within 4 weeks of FAPI PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start23 Feb 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fibroblast Activation Protein InhibitorStudies 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
- Experimental: 68Ga-FAPI PET/CT Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, Zhongnan Hospital
- Investigators
- Yong He, MD, PhD, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034146
- Sponsor's protocol ID
- ZNYYHYXK0001
- Status last verified
- May 2025
- First submitted
- 25 Aug 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kratochwil C, Flechsig P, Lindner T, Abderrahim L, Altmann A, Mier W, Adeberg S, Rathke H, Rohrich M, Winter H, Plinkert PK, Marme F, Lang M, Kauczor HU, Jager D, Debus J, Haberkorn U, Giesel FL. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019 Jun;60(6):801-805. doi: 10.2967/jnumed.119.227967. Epub 2019 Apr 6.
PubMed 30954939Pang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of 68Ga-FAPI and 18F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1.
PubMed 33258746Li H, Li C, Tian Y, Xiao Z, Xing D, He Y. Same-day dual-tracer PET/CT imaging with [68 Ga]Ga-FAPI-04 following [18F]FDG finds answers in patients presenting with negative or equivocal [18F]FDG. Ann Nucl Med. 2025 Nov;39(11):1237-1248. doi: 10.1007/s12149-025-02080-1. Epub 2025 Jul 4.
PubMed 40614035Jiang Y, Yu Z, Sun Y, Tian Y, Wang L, Xing D, Huang Y, He Y, Jia J. Predictive value of [68Ga]Ga-FAPI-04 PET/CT on pathologic response to neoadjuvant chemoimmunotherapy for locally advanced resectable oral squamous cell carcinoma. Eur J Nucl Med Mol Imaging. 2025 Dec;53(1):283-294. doi: 10.1007/s00259-025-07414-9. Epub 2025 Jun 23.
PubMed 40548990Jiang Y, Huang S, Tian Y, Xing D, Xiao Z, Huang J, He Y. Dual-Time Point 68 Ga-FAPI-04 PET/CT Improves Tumor Delineation and Cervical Lymph Node Metastasis Identification in Patients With Head and Neck Squamous Cell Carcinoma. Clin Nucl Med. 2025 Mar 1;50(3):e130-e137. doi: 10.1097/RLU.0000000000005610. Epub 2024 Dec 13.
PubMed 39668486Chen J, Xu K, Li C, Tian Y, Li L, Wen B, He C, Cai H, He Y. [68Ga]Ga-FAPI-04 PET/CT in the evaluation of epithelial ovarian cancer: comparison with [18F]F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):4064-4076. doi: 10.1007/s00259-023-06369-z. Epub 2023 Aug 1.
PubMed 37526694
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Efficiency of 68Ga-FAPI PET/CT in Malignant Tumors
- ClinicalTrials.gov ID
- NCT05034146
- Acronym / sponsor ID
- ZNYYHYXK0001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Sep 2021 (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 type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.
Detailed description
The morbidity and mortality of malignant tumors are increasing. It is one of the major diseases that affect human health. At present, the conventional imaging diagnosis methods of a variety of malignant tumors are mainly CT and MRI based on anatomical imaging. Different from traditional imaging methods to visually display the lesion, nuclear medicine molecular imaging can not only locate the tumor location, but also image the expression and activity of specific molecules and biological processes. This molecular imaging method integrating anatomy and function is a noninvasive imaging to realize the early diagnosis and differential diagnosis, curative effect evaluation and follow-up observation of a variety of tumors. Positron emission tomography/computed tomography (PET/CT) uses specific molecular probes to target tumor. It can provide detailed information about the biochemical changes of tumor tissues at the cellular and molecular levels. It has better sensitivity and specificity than conventional imaging methods. At present, the most commonly used imaging agent in clinic is 18F-fluorodeoxyglucose (18F-FDG). 18F-FDG PET/CT is a valuable imaging modality in the management of patients with malignant tumors, but it is not a specific imaging agent for tumor application. The physiological uptake of gastrointestinal tract, infected tissues, or inflammatory cells can cause high 18F-FDG uptake resulting in a significant increase of the false positive rate; in addition, some tumors including well-differentiated hepatocellular carcinoma, renal cell carcinoma, and gastric signet ring cell carcinoma have low 18F-FDG uptake resulting in a high false negative rate. Therefore, it is very important to develop new molecular probes for targeting tumor.
Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental: 68Ga-FAPI PET/CT Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI PET/CT in malignant tumors | Experimental | Drug: 68Ga-FAPI, Device: PET/CTInvestigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteering to participate in clinical trial and sign an informed consent form Patients with suspected or confirmed malignant tumor
Key exclusion criteria (1 listed)
- Female patients plan to become pregnant within 6 months Pregnant and lactating women Patients are allergic to multiple drugs including test drug Patients have participated in other clinical trials in the past one month
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 |
|---|---|---|
| 68Ga-FAPIAlso: 68Ga-fibroblast activation protein inhibitor68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg). | Drug | 68Ga-FAPI PET/CT in malignant tumors |
| PET/CTAlso: positron emission tomography/computed tomography68Ga-FAPI PET/CT scan were performed 20~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously. | Device | 68Ga-FAPI PET/CT in malignant tumors |
Primary outcome
The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors
Time frame: three years
Taking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-FAPI PET/CT in detecting malignant tumor were calculated.
3 secondary outcomes
Prognostic value of FAPI PET parameters in malignant tumors
Time frame: From baseline to 1 year post-treatment
FAPI PET for therapeutic response evaluation in malignant tumors
Time frame: Within 1 week after completion of neoadjuvant or adjuvant therapy
The connection between FAPI PET parameters and histopathological biomarkers.
Time frame: Within 4 weeks of FAPI PET scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 30954939Kratochwil C, Flechsig P, Lindner T, Abderrahim L, Altmann A, Mier W, Adeberg S, Rathke H, Rohrich M, Winter H, Plinkert PK, Marme F, Lang M, Kauczor HU, Jager D, Debus J, Haberkorn U, Giesel FL. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019 Jun;60(6):801-805. doi: 10.2967/jnumed.119.227967. Epub 2019 Apr 6.
- Background: PubMed 33258746Pang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of 68Ga-FAPI and 18F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1.
- Derived from this study: PubMed 40614035Li H, Li C, Tian Y, Xiao Z, Xing D, He Y. Same-day dual-tracer PET/CT imaging with [68 Ga]Ga-FAPI-04 following [18F]FDG finds answers in patients presenting with negative or equivocal [18F]FDG. Ann Nucl Med. 2025 Nov;39(11):1237-1248. doi: 10.1007/s12149-025-02080-1. Epub 2025 Jul 4.
- Derived from this study: PubMed 40548990Jiang Y, Yu Z, Sun Y, Tian Y, Wang L, Xing D, Huang Y, He Y, Jia J. Predictive value of [68Ga]Ga-FAPI-04 PET/CT on pathologic response to neoadjuvant chemoimmunotherapy for locally advanced resectable oral squamous cell carcinoma. Eur J Nucl Med Mol Imaging. 2025 Dec;53(1):283-294. doi: 10.1007/s00259-025-07414-9. Epub 2025 Jun 23.
- Derived from this study: PubMed 39668486Jiang Y, Huang S, Tian Y, Xing D, Xiao Z, Huang J, He Y. Dual-Time Point 68 Ga-FAPI-04 PET/CT Improves Tumor Delineation and Cervical Lymph Node Metastasis Identification in Patients With Head and Neck Squamous Cell Carcinoma. Clin Nucl Med. 2025 Mar 1;50(3):e130-e137. doi: 10.1097/RLU.0000000000005610. Epub 2024 Dec 13.
- Derived from this study: PubMed 37526694Chen J, Xu K, Li C, Tian Y, Li L, Wen B, He C, Cai H, He Y. [68Ga]Ga-FAPI-04 PET/CT in the evaluation of epithelial ovarian cancer: comparison with [18F]F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):4064-4076. doi: 10.1007/s00259-023-06369-z. Epub 2023 Aug 1.
- 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.
Yong He, MD, PhD principal investigator
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPI and PET/CT in people with Fibroblast Activation Protein Inhibitor and PET/CT, run by Zhongnan Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong He, MD, PhD (+86-27-67812698, vincentheyong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors (time frame: three years). 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 NCT05034146, which also lists 6 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 5 Jun 2025.