Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

Sun Yat-sen University

Status

Unknown

Conditions

Nasopharyngeal Carcinoma

Treatments

Device: ultrasensitive PET CT

Study type

Observational

Funder types

Other

Identifiers

NCT04394091

ultrasensitive PET/CT in NPC

Details and patient eligibility

About

NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study.

Full description

Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 8th) will be recruited. All subjects receiving chemoradiotherapy will undergo a baseline integrated [18F]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan or traditional follow-up examination before the start of chemoradiotherapy.

NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously 12 weeks after the end of chemoradiotherapy (primary endpoint).

The results of FDG PET/CT and high-sensitivity PET/CT analyzed and compared.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 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 18-70, male/female.
Staged III or IV (AJCC 8th) NPC patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III).
Received induction chemotherapy and/or concurrent chemoradiotherapy. ECOG scale 0-1.
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
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.