Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma

NCT05030597 | Recruiting

• 1 other identifier: PTXM2021021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. This study also aims to explore the application value of FAPI imaging in evaluating treatment response for oral cancer.

Conditions

PET/CT; FAPI; Oral Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (at initial diagnosis, prior to treatment)

Secondary Outcomes (3)

• FAPI PET for therapeutic response evaluation

  After completion of 2nd cycle of neoadjuvant therapy, just prior to surgery

• Prognostic value of FAPI PET parameters in oral cancer

  Through study completion, an average of 1 year

• Correlation between FAPI PET parameters and histopathological biomarkers

  At baseline and 6 weeks post-FAPI PET scan

Study Arms (1)

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.

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.

Interventions

68Ga-DOTA-FAPI DRUG

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.

Also known as: gallium-68 (68Ga)-Fibroblast activation protein inhibitor (FAPI)

68Ga-DOTA-FAPI and 18F-FDG PET/CT

PET/CT DEVICE

Each subject undergoes PET/CT imaging within 20-30 minutes after injection.

Also known as: Positron Emission Tomography/Computed Tomography

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. DIAGNOSTIC_TEST

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.

68Ga-DOTA-FAPI and 18F-FDG PET/CT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 32601975 BACKGROUND

• Syed 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.

  PMID: 32447444 BACKGROUND

• Chen 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.

  PMID: 32222810 BACKGROUND

• Jiang 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.

  PMID: 40548990 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Gallium-68; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• He Yong, PhD

  Zhongnan Hospital

  STUDY CHAIR

Central Study Contacts

Jiang Yaqun, PhD

CONTACT

0086-027-67812698; zn004239@whu.edu.cn

He Yong, PhD

CONTACT

0086-027-67812698; vincentheyong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: September 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)