uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Device: ultrasensitive positron emission tomography

• Registration Number: NCT04394065
• Lead Sponsor: Sun Yat-sen University

Brief Summary

uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-19
• Study Start: 2020-06-20
• Primary Completion: 2021-02-20
• Study Completion: 2021-06-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-12
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
uEXPLORER total-body PET/CT	ultrasensitive positron emission tomography	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

Primary Outcome Measures

Name	Time	Method
The results of uEXPLORER Total-body PET/CT	6 months	The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China