Clinical trial NCT04394065: uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma
Official title: Potential of uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma: The Dynamic Imaging, Kinetic Parameters, and Comparison With Conventional PET/CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma
Keywords: ultrasensitive PET CT
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newly diagnosed NPC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The results of uEXPLORER Total-body PET/CT
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT
timeFrame: 6 months
measure: Protocol of TB-PET/CT in NPC
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Haiqiang Mai, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 Biol. 2019 Mar 21;64(7):075004. doi: 10.1088/1361-6560/aafc6c.