Completed

NCT Number: NCT05990998

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

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.

Completed

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Key information

Conditions

Tumor Positron-Emission Tomography

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-DOTATATE and 68Ga-FAPI

Drug

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.

Primary outcomes

SUVmax

Time frame: 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

Time frame: through study completion, an average of 2 years

Determination of lesion numbers of 68Ga-FAPI and 68Ga-DOTATATE scan.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title