Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04394091
• Other study ID #: ultrasensitive PET/CT in NPC
• Status: Not yet recruiting
• Start date: May 20, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: May 2020
• Source: Sun Yat-sen University
• Contact: Haiqiang Mai, Dr
• Phone: 86-20-8734-3643
• Email: maihq[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Device:
• ultrasensitive PET CT
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. Its total-body coverage and exceptional sensitivity provide opportunities for innovative studies of physiology, biochemistry, and pharmacology.

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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 Bi — View 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. — View Citation

Zhang X, Xie Z, Berg E, Judenhofer MS, Liu W, Xu T, Ding Y, Lv Y, Dong Y, Deng Z, Tang S, Shi H, Hu P, Chen S, Bao J, Li H, Zhou J, Wang G, Cherry SR, Badawi RD, Qi J. Total-Body Dynamic Reconstruction and Parametric Imaging on the uEXPLORER. J Nucl Med. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	results of ultrasensitive and normal PET CT	The results of the two tests were compared to verify the specificity and sensitivity of ultrasensitive PET CT in post treatment NPC	6 months