PET/CTFAPI-OSCCNCT05030597
Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma
An observational study of PET/CT and FAPI, run by Zhongnan Hospital at 1 site in China.
Trial summary
In this prospective study, the investigators will use integrated PET/CT with the agent 68Ga-FAPI and conventional imaging agent 18F-FDG to explore the application value of FAP-targeted molecular imaging in the diagnosis and staging for oral cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PET/CT, FAPI, Oral Cancer
- What is being tested?
- 68Ga-DOTA-FAPI, PET/CT and Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2021to 31 Dec 2025
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolls adults aged 18-70 years with clinically suspected or histopathologically confirmed oral cancer (primary or recurrent). Newly diagnosed patients are scheduled for surgery or neoadjuvant therapy, while recurrent cases require imaging/pathology confirmation. All participants must complete baseline FAPI PET/CT and FDG PET/CT for diagnostic/staging evaluation. Locally advanced patients receiving neoadjuvant therapy will undergo follow-up FAPI PET/CT for therapeutic response assessment. Exclusion criteria include pregnancy, severe allergies to FAPI/FDG, uncontrolled comorbidities, and recent participation in other interventional trials.
Who may be able to join
- Voluntary participation with signed informed consent;
- Aged 18~70 years;
- Clinically highly suspected oral cancer and recurrence after treatment (Newly diagnosed patients: Scheduled for surgery or neoadjuvant therapy followed by surgery);
- Ability to complete baseline and follow-up PET/CT (Follow-up FAPI PET/CT applies only to locally advanced patients undergoing neoadjuvant therapy.).
Who cannot join
- Pregnant or breastfeeding women, or women planning pregnancy during the trial period;
- Known hypersensitivity to FAPI, FDG, or their components, or history of severe allergic reactions;
- People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;
- Before the injection of 18F-FDG, the fasting blood glucose level exceeded 11.0 mmol/L;
- Claustrophobia or inability to tolerate PET/CT imaging (Those who cannot tolerate lying supine for 15~30 minutes.);
- Participation in another interventional clinical trial within 30 days prior to enrollment, or planned participation during this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, 430071
Yaqun Jiang, PhD, MD, 027-67812837, zn004239@whu.edu.cn
Yong He, PhD, MD, 027-67812837, vincentheyong@163.com
About this study
In this prospective study, the investigators will use integrated PET/CT with the agent 68Ga-FAPI and conventional imaging agent 18F-FDG to explore the application value of FAP-targeted molecular imaging in the diagnosis and staging for oral cancer. This study also aims to explore the application value of FAPI imaging in evaluating treatment response for oral cancer.
Read the detailed description
Positron emission tomography (PET) molecular imaging provides a valuable method for the diagnosis, differential diagnosis and staging of various tumors. Cancer associated fibroblasts (CAFs) are the main components of tumor stroma, which are involved in tumor cell proliferation, invasion, metastasis and tumor angiogenesis, and play an important role in the occurrence and development of tumors. Fibroblast activation protein (FAP) is the most potential specific molecular marker of CAF, which is mainly expressed in stromal fibroblasts of epithelial tumors and is a potential molecular target for tumor diagnosis and treatment. Oral cancer is the most common type of malignant head and neck cancer, seriously endangering human health. Accurate delineation of the primary tumor, detection of regional nodal metastases, distant metastases and second primary tumors are important for determining the therapeutic strategy and prognosis of oral cancer. Currently, the molecular imaging agent most commonly used in clinical practice for oral cancer is 18F-fluoro-deoxy-glucose (18F-FDG). However, 18F-FDG exhibits some shortages. Inflammatory lesions and the surrounding normal tissue such as brain, tonsils and salivary glands show high uptake of 18F-FDG, often affecting the judgment of lesions.
Adult patients aged >18 years with clinically confirmed or highly suspected oral cancer will be enrolled. Participants receive paired baseline FDG and FAPI PET/CT to explore the diagnostic and staging value of FAPI PET in oral cancer. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery to evaluate its application in treatment-response assessment. Ultimately, this study aims to comprehensively evaluate the clinical utility of FAPI PET/CT in oral cancer.
- Conditions
- PET/CT, FAPI, Oral Cancer
- Being tested
- 68Ga-DOTA-FAPI, PET/CT, Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-FAPIDrug
Also called gallium-68 (68Ga)-Fibroblast activation protein inhibitor (FAPI)
Intravenous access is pre-established. Quality control is carried out to confirm the radiochemical purity of 68Ga-DOTA-FAPI by HPLC. Intravenous administration of 68Ga-DOTA-FAPI according to 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.
PET/CTDevice
Also called Positron Emission Tomography/Computed Tomography
Each subject undergoes PET/CT imaging within 20-30 minutes after injection.
Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.Diagnostic test
This observational study evaluates the application of paired FDG and FAPI PET/CT in oral cancer.
- Baseline phase: All participants undergo baseline FDG and FAPI PET/CT scans.
- Post-neoadjuvant phase: For patients with resectable locally advanced disease receiving neoadjuvant therapy (as per clinician decision), a second FAPI PET/CT scan is performed after 2 cycles of treatment to assess treatment response.
- Purpose: To explore the utility of FAPI PET in (a) initial staging, (b) treatment response evaluation, and (c) prognostic value in oral cancer.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTA-FAPI and 18F-FDG PET/CT | Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET/CTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery. Receives: Drug: 68Ga-DOTA-FAPI; Device: PET/CT; Diagnostic Test: Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (sensitivity, specificity, accuracy) and staging of FAPI PET in oral cancer
Comparison of FAPI PET and FDG PET in diagnosing oral cancer, including sensitivity, specificity, accuracy, and TNM staging. Assessments performed at baseline using histopathology and imaging as reference standards.
Measured: Baseline (at initial diagnosis, prior to treatment)
Secondary outcomes (3)
FAPI PET for therapeutic response evaluation
Assessment of FAPI PET parameters for predicting treatment response in patients receiving neoadjuvant therapy. Follow-up FAPI PET performed post-treatment.
Measured: After completion of 2nd cycle of neoadjuvant therapy, just prior to surgery
Prognostic value of FAPI PET parameters in oral cancer
Correlation between FAPI PET parameters and long-term outcomes (e.g., progression-free survival, overall survival).
Measured: Through study completion, an average of 1 year
Correlation between FAPI PET parameters and histopathological biomarkers
Correlation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak) and histopathological biomarkers of tumor tissue.
- FAP expression level (H-score; immunohistochemistry)
- PD-L1 expression (Combined Positive Score; Dako 22C3 IHC assay)
- CD8 expression (H-score; immunohistochemistry)
- Granzyme B expression (H-score; immunohistochemistry)
Measured: At baseline and 6 weeks post-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 posted1 Sep 2021
- Study start15 Sep 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 (4)Papers the sponsor has linked to this study.
- Other trials for PET/CTStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Yong, PhD, Study chair, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030597
- Sponsor's protocol ID
- PTXM2021021
- Acronym
- FAPI-OSCC
- Status last verified
- Jul 2024
- First submitted
- 26 Aug 2021
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fitzgerald AA, Weiner LM. The role of fibroblast activation protein in health and malignancy. Cancer Metastasis Rev. 2020 Sep;39(3):783-803. doi: 10.1007/s10555-020-09909-3.
PubMed 32601975Syed M, Flechsig P, Liermann J, Windisch P, Staudinger F, Akbaba S, Koerber SA, Freudlsperger C, Plinkert PK, Debus J, Giesel F, Haberkorn U, Adeberg S. Fibroblast activation protein inhibitor (FAPI) PET for diagnostics and advanced targeted radiotherapy in head and neck cancers. Eur J Nucl Med Mol Imaging. 2020 Nov;47(12):2836-2845. doi: 10.1007/s00259-020-04859-y. Epub 2020 May 23.
PubMed 32447444Chen H, Pang Y, Wu J, Zhao L, Hao B, Wu J, Wei J, Wu S, Zhao L, Luo Z, Lin X, Xie C, Sun L, Lin Q, Wu H. Comparison of [68Ga]Ga-DOTA-FAPI-04 and [18F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of cancer. Eur J Nucl Med Mol Imaging. 2020 Jul;47(8):1820-1832. doi: 10.1007/s00259-020-04769-z. Epub 2020 Mar 28.
PubMed 32222810Jiang 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 40548990
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05030597
- Acronym / sponsor ID
- FAPI-OSCC / PTXM2021021
- Conditions
- PET/CT, FAPI, Oral Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 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.
In this prospective study, the investigators will use integrated PET/CT with the agent 68Ga-FAPI and conventional imaging agent 18F-FDG to explore the application value of FAP-targeted molecular imaging in the diagnosis and staging for oral cancer. This study also aims to explore the application value of FAPI imaging in evaluating treatment response for oral cancer.
Detailed description
Positron emission tomography (PET) molecular imaging provides a valuable method for the diagnosis, differential diagnosis and staging of various tumors. Cancer associated fibroblasts (CAFs) are the main components of tumor stroma, which are involved in tumor cell proliferation, invasion, metastasis and tumor angiogenesis, and play an important role in the occurrence and development of tumors. Fibroblast activation protein (FAP) is the most potential specific molecular marker of CAF, which is mainly expressed in stromal fibroblasts of epithelial tumors and is a potential molecular target for tumor diagnosis and treatment. Oral cancer is the most common type of malignant head and neck cancer, seriously endangering human health. Accurate delineation of the primary tumor, detection of regional nodal metastases, distant metastases and second primary tumors are important for determining the therapeutic strategy and prognosis of oral cancer. Currently, the molecular imaging agent most commonly used in clinical practice for oral cancer is 18F-fluoro-deoxy-glucose (18F-FDG). However, 18F-FDG exhibits some shortages. Inflammatory lesions and the surrounding normal tissue such as brain, tonsils and salivary glands show high uptake of 18F-FDG, often affecting the judgment of lesions.
Adult patients aged >18 years with clinically confirmed or highly suspected oral cancer will be enrolled. Participants receive paired baseline FDG and FAPI PET/CT to explore the diagnostic and staging value of FAPI PET in oral cancer. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery to evaluate its application in treatment-response assessment. Ultimately, this study aims to comprehensively evaluate the clinical utility of FAPI PET/CT in oral cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTA-FAPI and 18F-FDG PET/CT | – | Drug: 68Ga-DOTA-FAPI, Device: PET/CT, Diagnostic Test: Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET/CTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolls adults aged 18-70 years with clinically suspected or histopathologically confirmed oral cancer (primary or recurrent). Newly diagnosed patients are scheduled for surgery or neoadjuvant therapy, while recurrent cases require imaging/pathology confirmation. All participants must complete baseline FAPI PET/CT and FDG PET/CT for diagnostic/staging evaluation. Locally advanced patients receiving neoadjuvant therapy will undergo follow-up FAPI PET/CT for therapeutic response assessment. Exclusion criteria include pregnancy, severe allergies to FAPI/FDG, uncontrolled comorbidities, and recent participation in other interventional trials.
Key inclusion criteria (4 listed)
- Voluntary participation with signed informed consent;
- Aged 18~70 years;
- Clinically highly suspected oral cancer and recurrence after treatment (Newly diagnosed patients: Scheduled for surgery or neoadjuvant therapy followed by surgery);
- Ability to complete baseline and follow-up PET/CT (Follow-up FAPI PET/CT applies only to locally advanced patients undergoing neoadjuvant therapy.).
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women, or women planning pregnancy during the trial period;
- Known hypersensitivity to FAPI, FDG, or their components, or history of severe allergic reactions;
- People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;
- Before the injection of 18F-FDG, the fasting blood glucose level exceeded 11.0 mmol/L;
- Claustrophobia or inability to tolerate PET/CT imaging (Those who cannot tolerate lying supine for 15~30 minutes.);
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-DOTA-FAPIAlso: gallium-68 (68Ga)-Fibroblast activation protein inhibitor (FAPI)Intravenous access is pre-established. Quality control is carried out to confirm the radiochemical purity of 68Ga-DOTA-FAPI by HPLC. Intravenous administration of 68Ga-DOTA-FAPI according to 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water. | Drug | 68Ga-DOTA-FAPI and 18F-FDG PET/CT |
| PET/CTAlso: Positron Emission Tomography/Computed TomographyEach subject undergoes PET/CT imaging within 20-30 minutes after injection. | Device | 68Ga-DOTA-FAPI and 18F-FDG PET/CT |
| Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging.This observational study evaluates the application of paired FDG and FAPI PET/CT in oral cancer. 1. Baseline phase: All participants undergo baseline FDG and FAPI PET/CT scans. 2. Post-neoadjuvant phase: For patients with resectable locally advanced disease receiving neoadjuvant therapy (as per clinician decision), a second FAPI PET/CT scan is performed after 2 cycles of treatment to assess treatment response. 3. Purpose: To explore the utility of FAPI PET in (a) initial staging, (b) treatment response evaluation, and (c) prognostic value in oral cancer. | Diagnostic test | 68Ga-DOTA-FAPI and 18F-FDG PET/CT |
Primary outcome
Diagnostic performance (sensitivity, specificity, accuracy) and staging of FAPI PET in oral cancer
Time frame: Baseline (at initial diagnosis, prior to treatment)
Comparison of FAPI PET and FDG PET in diagnosing oral cancer, including sensitivity, specificity, accuracy, and TNM staging. Assessments performed at baseline using histopathology and imaging as reference standards.
3 secondary outcomes
FAPI PET for therapeutic response evaluation
Time frame: After completion of 2nd cycle of neoadjuvant therapy, just prior to surgery
Prognostic value of FAPI PET parameters in oral cancer
Time frame: Through study completion, an average of 1 year
Correlation between FAPI PET parameters and histopathological biomarkers
Time frame: At baseline and 6 weeks post-FAPI PET scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 32601975Fitzgerald AA, Weiner LM. The role of fibroblast activation protein in health and malignancy. Cancer Metastasis Rev. 2020 Sep;39(3):783-803. doi: 10.1007/s10555-020-09909-3.
- Background: PubMed 32447444Syed M, Flechsig P, Liermann J, Windisch P, Staudinger F, Akbaba S, Koerber SA, Freudlsperger C, Plinkert PK, Debus J, Giesel F, Haberkorn U, Adeberg S. Fibroblast activation protein inhibitor (FAPI) PET for diagnostics and advanced targeted radiotherapy in head and neck cancers. Eur J Nucl Med Mol Imaging. 2020 Nov;47(12):2836-2845. doi: 10.1007/s00259-020-04859-y. Epub 2020 May 23.
- Background: PubMed 32222810Chen H, Pang Y, Wu J, Zhao L, Hao B, Wu J, Wei J, Wu S, Zhao L, Luo Z, Lin X, Xie C, Sun L, Lin Q, Wu H. Comparison of [68Ga]Ga-DOTA-FAPI-04 and [18F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of cancer. Eur J Nucl Med Mol Imaging. 2020 Jul;47(8):1820-1832. doi: 10.1007/s00259-020-04769-z. Epub 2020 Mar 28.
- 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.
- 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.
He Yong, PhD study chair
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PET/CT and FAPI, 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 4 inclusion and 6 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 28 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Yaqun, PhD (0086-027-67812698, zn004239@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (sensitivity, specificity, accuracy) and staging of FAPI PET in oral cancer (time frame: Baseline (at initial diagnosis, prior to treatment)). 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 NCT05030597, 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 28 May 2025.