Clinical trial NCT04394091: Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients
Official title: Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: high-sensitivity PET CT
PET CT
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NPC patients after induction chemotherapy and concurrent chemoradiotherapy or concurrent chemoradiotherapy alone

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.

Eligibility criteria: 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.

Primary outcomes:
measure: results of ultrasensitive and normal PET CT
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Haiqiang Mai, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. 2020 Feb;61(2):285-291. doi: 10.2967/jnumed.119.230565. Epub 2019 Jul 13.
citation: 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 Biol. 2019 Mar 21;64(7):075004. doi: 10.1088/1361-6560/aafc6c.