Skip to main content
OpenTrials
Completed

NCT Number: NCT04394065

uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasensitive positron emission tomography

Device

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

Other names: conventional PET/CT

Primary outcomes

  1. The results of uEXPLORER Total-body PET/CT

    Time frame: 6 months

    The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT

Secondary outcomes

  1. Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT

    Time frame: 6 months

    Image quality and Static Lesion detectability of TB-PET/CT and conventional PET/CT

  2. Protocol of TB-PET/CT in NPC

    Time frame: 6 months

    Acquisition time and low dose simulation of TB-PET/CT

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 19, 2020
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.