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

First Affiliated Hospital of Fujian Medical University

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05990998

Enrollment

Registered

2023-08-14

Start date

2022-11-20

Completion date

2023-09-01

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor Positron-Emission Tomography

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.

Interventions

DRUG68Ga-DOTATATE and 68Ga-FAPI

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026