Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Device: ultrasensitive PET CT

• Registration Number: NCT04394091
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19
• Study Start: 2020-05-20
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PET CT and ultrasensitive PET CT	ultrasensitive PET CT	Patients receiving chemoradiotherapy will receive a dedicated FDG PET/CT and ultrasensitive PET CT protocol 12 weeks after the end of IMRT .

Primary Outcome Measures

Name	Time	Method
results of ultrasensitive and normal PET CT	6 months	The results of the two tests were compared to verify the specificity and sensitivity of ultrasensitive PET CT in post treatment NPC

Trial Locations

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China