uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394065
• Other study ID #: 2020-5-13 high-sensitivity PET
• Status: Completed
• Start date: June 20, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 20, 2021
• Est. primary completion date: February 20, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Device:
• ultrasensitive positron emission tomography
A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER)

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Lv Y, Lv X, Liu W, Judenhofer MS, Zwingenberger A, Wisner E, Berg E, McKenney S, Leung E, Spencer BA, Cherry SR, Badawi RD. Mini EXPLORER II: a prototype high-sensitivity PET/CT scanner for companion animal whole body and human brain scanning. Phys Med Bi — View Citation

Zhang X, Cherry SR, Xie Z, Shi H, Badawi RD, Qi J. Subsecond total-body imaging using ultrasensitive positron emission tomography. Proc Natl Acad Sci U S A. 2020 Feb 4;117(5):2265-2267. doi: 10.1073/pnas.1917379117. Epub 2020 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The results of uEXPLORER Total-body PET/CT	The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT	6 months
Secondary	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
Secondary	Protocol of TB-PET/CT in NPC	Acquisition time and low dose simulation of TB-PET/CT	6 months