NCT03601390

Combining PET/CT and EBV DNA to Evaluate the Hazard of Progression in the Follow-up of Locally Advanced NPC

Combining Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography and Plasma EBV DNA to Evaluate the Hazard of Progression in the Follow-up of Locally Advanced Nasopharyngeal Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 387 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

PET/CT and EBV DNA are important in diagnosis of NPC. We consider that combining post-treament PET/CT and plasma EBV DNA may be effective in evaluating the hazard of progression in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study.

Detailed description

Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 7th) will be recruited. All subjects receiving chemoradiotherapy will undergo a baseline integrated \[18F\]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan or traditional follow-up examination and plasma EBV DNA test before the start of chemoradiotherapy. Patients receiving IMRT treatment will receive a dedicated FDG PET/CT protocol 12 weeks after the end of chemoradiotherapy (primary endpoint).Plasma EBV DNA test will be performed 4, 12, 24 weeks after the end of IMRT treatment. In patients with negative PET/CT results, 2 follow-up visits are required to complement nasopharyngoscope examination and plasma EBV DNA test in the frist year. All patients will undergo annual PET/CT or traditional follow-up examination and plasma EBV DNA test 1 year after completing chemoradiation unless recurrent/residual disease is histopathologically-confirmed. Patients with a PET/CT result suspecting for residual/recurrent/metastatic tumor must have pathological and/or clinical evidence of tumor existence before salvage therapy is started.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DEVICE	PET/CT and EBV DNA	PET/CT and EBV DNA will be proformed after the IMRT treatment

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-12-12
• Completion: 2020-12-12
• First posted: 2018-07-26
• Last updated: 2020-12-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study