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

Fujian Medical University (FJMU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Tumor Positron-Emission Tomography

Treatments: Drug: 68Ga-DOTATATE and 68Ga-FAPI

Study type: Interventional

Funder types: Other

Identifiers

NCT05990998

First AHFujian

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT

Experimental group

Description:

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.

Treatment:

Drug: 68Ga-DOTATATE and 68Ga-FAPI