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Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma (FAPI-OSCC)

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ClinicalTrials.gov Identifier: NCT05030597
Recruitment Status : Not yet recruiting
First Posted : September 1, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Zhongnan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
PET/CT FAPI Oral Cancer Drug: 68Ga-DOTA-FAPI Device: PET/CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma
Estimated Study Start Date : September 15, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: 68Ga-DOTA-FAPI and 18F-FDG PET/CT
Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo 68Ga-DOTA-FAPI and 18F-FDG PET/CT imaging within one week.
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.
Other Name: gallium-68 (68Ga)-Fibroblast activation protein inhibitor (FAPI)

Device: PET/CT
Each subject undergoes PET/CT imaging within 20-30 minutes after injection.
Other Name: Positron Emission Tomography/Computed Tomography




Primary Outcome Measures :
  1. Sensitivity of 68Ga-DOTA-FAPI PET/CT for diagnosis and staging in oral cancer. [ Time Frame: 3 years ]
    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.

  2. Specificity of 68Ga-DOTA-FAPI PET/CT for diagnosis and staging in oral cancer. [ Time Frame: 3 years ]
    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. rang of primary lesions [ Time Frame: 3 years ]
    Compare the 68Ga-DOTA-FAPI and 18F-FDG PET/CT for the rang of primary lesions.

  4. number of metastatic lesions [ Time Frame: 3 years ]
    Compare the 68Ga-DOTA-FAPI and 18F-FDG PET/CT for the number of metastatic lesions.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05030597


Contacts
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Contact: Jiang Yaqun, PhD 0086-027-67812698 zn004239@whu.edu.cn

Sponsors and Collaborators
Zhongnan Hospital
Publications:
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Responsible Party: Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT05030597    
Other Study ID Numbers: PTXM2021021
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Mouth Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases