uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

Sun Yat-sen University

Status: Completed

Conditions: Nasopharyngeal Carcinoma

Treatments: Device: ultrasensitive positron emission tomography

Study type: Observational

Funder types: Other

Identifiers

NCT04394065

2020-5-13 high-sensitivity PET

Details and patient eligibility

About

uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

56 participants in 1 patient group

uEXPLORER total-body PET/CT

Description:

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

Treatment:

Device: ultrasensitive positron emission tomography