Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

Study Overview
=================
Brief Summary
-----------------
NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously 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 8th) 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 before the start of chemoradiotherapy. NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously 12 weeks after the end of chemoradiotherapy (primary endpoint). The results of FDG PET/CT and high-sensitivity PET/CT analyzed and compared.

Official Title
-----------------
Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Device: ultrasensitive PET CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be informed of the investigational nature of this study and given written informed consent. Aged between 18-70, male/female. Staged III or IV (AJCC 8th) NPC patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III). Received induction chemotherapy and/or concurrent chemoradiotherapy. ECOG scale 0-1. Fertile women should practice contraception during the study period. HGB ≥90g/L ,WBC ≥4*109/L , PLT ≥100*109/L, With normal liver function test (ALT and AST ≤2.5*ULN, TBil ≤2.0*ULN) With normal renal function test (serum creatinine ≤1.5*ULN) Exclusion Criteria: Women in pregnancy or lactation Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance. Already involved in other clinical trial. Mental disorder, civil disability, limited capacity for civil conduct.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PET CT and ultrasensitive PET CT<br>Patients receiving chemoradiotherapy will receive a dedicated FDG PET/CT and ultrasensitive PET CT protocol 12 weeks after the end of IMRT . | Device: ultrasensitive PET CT<br>* A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. Its total-body coverage and exceptional sensitivity provide opportunities for innovative studies of physiology, biochemistry, and pharmacology.<br>* Other names: PET CT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| results of ultrasensitive and normal PET CT | The results of the two tests were compared to verify the specificity and sensitivity of ultrasensitive PET CT in post treatment NPC | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high-sensitivity PET CT, PET CT