Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

NCT04394091 | Unknown DMC FDA Device

• 1 other identifier: ultrasensitive PET/CT in NPC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

high-sensitivity PET CT; PET CT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PET CT and ultrasensitive PET CT

Patients receiving chemoradiotherapy will receive a dedicated FDG PET/CT and ultrasensitive PET CT protocol 12 weeks after the end of IMRT .

Device: ultrasensitive PET CT

Interventions

ultrasensitive PET CT DEVICE

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.

Also known as: PET CT

PET CT and ultrasensitive PET CT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NPC patients after induction chemotherapy and concurrent chemoradiotherapy or concurrent chemoradiotherapy alone

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (3)

• 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.

  PMID: 31964808 RESULT

• 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.

  PMID: 31302637 RESULT

• 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.

  PMID: 30620929 RESULT

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Haiqiang Mai, Dr

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiqiang Mai, Dr

CONTACT

86-20-8734-3643; maihq@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 19, 2020
• Study Start: May 20, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)