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

Phase 1

Completed

• Conditions: Tumor Positron-Emission Tomography
• Interventions: Drug: 68Ga-DOTATATE and 68Ga-FAPI

• Registration Number: NCT05990998
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-11-20
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-14
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients will undergo a 68Ga-FAPI PET/CT and 68Ga-DOTATATE PET/CT	68Ga-DOTATATE and 68Ga-FAPI	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China