A Head-to-head Comparison of [68Ga]Ga-FAPI and [68Ga]Ga-TATE PET/CT in Patients With Nasopharyngeal Carcinoma: a Single-center, Prospective Study

Study Overview
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Brief Summary
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Both fibroblast activation protein (FAP)-targeted imaging and somatostatin receptors (SSTR)-targeted imaging were the promising imaging modalities for the diagnosis of primary and metastatic nasopharyngeal carcinoma (NPC). This prospective study is going to investigate to compare the diagnostic efficacy of 68Ga-FAPI and 68Ga-DOTATATE in detecting primary and metastatic NPC lesions, thereby obtaining a more accurate examination method of NPC.

Detailed Description
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Patients with newly diagnosed or previously treated NPC will be recruited in this study. Each patient received an intravenous injection of 68Ga-DOTATATE (2-4mCi) on the first day and 68Ga-FAPI (2-4mCi) on the second day. Whole-body PET/CT scans were performed at 40-60 min after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and lesion uptake were compared.

Official Title
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First Affiliated Hospital of Fujian Medical University

Conditions
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Tumor Positron-Emission Tomography

Intervention / Treatment
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* Drug: 68Ga-DOTATATE and 68Ga-FAPI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either gender, aged ≥ 18 years. Patients with newly diagnosed or previously treated NPC A diagnostic magnetic resonance imaging (MRI) of the tumor region within the previous 1 weeks prior to dosing day is available. signed written consent. Exclusion Criteria: pregnancy breastfeeding the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT<br>NPC patients receive a single intravenous injection of 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT (2-4mCi) PET/CT,and undergo PET/CT scan at 40-60 min post-injection. | Drug: 68Ga-DOTATATE and 68Ga-FAPI<br>* Each patient receive a single intravenous injection of 68Ga-FAPI or 68Ga-DOTATATE (2-4mCi) , and undergo PET/CT scan at 40-60 min post injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax | Determination of SUV for detected lesions and discernible organs of 68Ga-FAPI and 68Ga-DOTATATE scan. | through study completion, an average of 2 years | 
| Lesion numbers | Determination of lesion numbers of 68Ga-FAPI and 68Ga-DOTATATE scan. | through study completion, an average of 2 years |