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

Oral Cancer Clinical Trial

— FAPI-OSCC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05030597
• Other study ID #: PTXM2021021
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. 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.

Description:

Inclusion criteria were as follows: (i) adult patients (18 years or older); (ii) pathologically confirmed or highly suspected HNSCC; (iii) clinically suspected recurrence of HNSCC; (iv) underwent paired 18F-FDG and 68Ga-FAPI PET/CT within one week. The exclusion criteria were as follows: (i) received anticancer therapy within 3 months before PET/CT scan; (ii) hyperglycemia (fasting glucose > 11.1 mmol/L); (iii) patients failing to complete both PET/CT scans; (iv) the final pathological findings showed non-SCC; (v) patients with second primary tumor; (vi) patients with unknown primary tumor.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Volunteered to participate in this study and signed informed consent;

2. Age range from 18 to 70 years;

3. Clinically highly suspected oral cancer and recurrence after treatment, obtaining pathology results and planning surgery;

4. Willing and able to follow schedule visits, treatment plans and laboratory tests;

5. The clinical laboratory general biochemical examination (heart, liver, kidney, blood routine) and other indicators are in the normal range or abnormal without clinical significance.

Exclusion Criteria:

1. Female patients who plan to become pregnant within 6 months, or are pregnant or breastfeeding;

2. Those who are allergic to test drugs, allergic constitution, or allergic to multiple drugs;

3. People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;

4. Before the injection of 18F-FDG, the fasting blood glucose level exceeded 11.0 mmol/L;

5. The weight exceeds 100 kg;

6. Patients with claustrophobia;

7. Those who cannot tolerate lying supine for 15~30 minutes;

8. Researchers think it is inappropriate to participate in this clinical trial;

9. Those who have participated in clinical trials or are participating in other clinical trials in the past month.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Mouth Neoplasms
• Oral Cancer
• PET/CT
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• 68Ga-DOTA-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.

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

Locations

Country	Name	City	State
China	Zhongnan Hopital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of 68Ga-DOTA-FAPI PET/CT for diagnosis and staging in oral cancer.	For subjects with clinically highly suspected oral cancer or recurrence after treatment who undergo 68Ga-DOTA-FAPI and 18F-FDG PET/CT in one week. Diagnosis and staging results of 68Ga-DOTA-FAPI PET/CT will be compared to 18F-FDG PET/CT imaging, pathology, clinical and follow-up results.	3 years
Primary	Specificity of 68Ga-DOTA-FAPI PET/CT for diagnosis and staging in oral cancer.	For subjects with clinically highly suspected oral cancer or recurrence after treatment who undergo 68Ga-DOTA-FAPI and 18F-FDG PET/CT in one week. Diagnosis and staging results of 68Ga-DOTA-FAPI PET/CT will be compared to 18F-FDG PET/CT imaging, pathology, clinical and follow-up results.	3 years
Primary	rang of primary lesions	Compare the 68Ga-DOTA-FAPI and 18F-FDG PET/CT for the rang of primary lesions.	3 years
Primary	number of metastatic lesions	Compare the 68Ga-DOTA-FAPI and 18F-FDG PET/CT for the number of metastatic lesions.	3 years