Brief Title
Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients
Official Title
Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients
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 Type
Observational [Patient Registry]
Primary Outcome
results of ultrasensitive and normal PET CT
Condition
Nasopharyngeal Carcinoma
Intervention
ultrasensitive PET CT
Study Arms / Comparison Groups
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 .
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
May 20, 2020
Completion Date
December 20, 2020
Primary Completion Date
December 20, 2020
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.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Haiqiang Mai, Dr, 86-20-8734-3643, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04394091
Organization ID
ultrasensitive PET/CT in NPC
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Haiqiang Mai, Dr, Principal Investigator, Sun Yat-sen University
Verification Date
May 2020