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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04394091
Other study ID # ultrasensitive PET/CT in NPC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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