uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

Detailed Description
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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. The objective of this study is to determine its specific effect in newly diagnosed nasopharyngeal carcinoma compared with conventional PET/CT and the quantitative kinetic parameters including glucose metabolic rate (Ki), glucose transport rate of flow-in (k1) and flow-out (k2) between tissue and blood, and glucosamine-6-phosphatization rate in tissue (k3). All the neck lymph nodes suspected for metastatic in PET/CT were biopsied under the guidance of ultrasound for a pathological diagnosis.

Official Title
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Potential of uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma: The Dynamic Imaging, Kinetic Parameters, and Comparison With Conventional PET/CT

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Device: ultrasensitive positron emission tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be informed of the investigational nature of this study and given written informed consent. Aged between 18-65, male/female. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III).. 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 Patients with diabetes 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
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| uEXPLORER total-body PET/CT<br>Newly diagnosed NPC patients will undergo a one-hour total-body dynamic PET/CT examination and subsequently followed by a conventional PET/CT scan within 30 minutes | Device: ultrasensitive positron emission tomography<br>* A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER)<br>* Other names: conventional PET/CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The results of uEXPLORER Total-body PET/CT | The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT | Image quality and Static Lesion detectability of TB-PET/CT and conventional PET/CT | 6 months | 
| Protocol of TB-PET/CT in NPC | Acquisition time and low dose simulation of TB-PET/CT | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasensitive PET CT