Clinical trial · Observational
Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients
NCT04394091CI-TRIAL-00045152unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultrasensitive PET CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PET CT and ultrasensitive PET CT
- description
- Patients receiving chemoradiotherapy will receive a dedicated FDG PET/CT and ultrasensitive PET CT protocol 12 weeks after the end of IMRT .
- interventionNames
- Device: ultrasensitive PET CT
Primary outcomes (1)
- measure
- results of ultrasensitive and normal PET CT
- timeFrame
- 6 months
- description
- The results of the two tests were compared to verify the specificity and sensitivity of ultrasensitive PET CT in post treatment NPC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTZhang 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. PMID 31964808
- RESULTZhang 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. PMID 31302637
- RESULTLv 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. PMID 30620929