uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

NCT04394065 | Completed DMC FDA Device

• 1 other identifier: 2020-5-13 high-sensitivity PET
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

Conditions

Nasopharyngeal Carcinoma

Keywords

ultrasensitive PET CT

Outcome Measures

Primary Outcomes (1)

• The results of uEXPLORER Total-body PET/CT

  The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT

  6 months

Secondary Outcomes (2)

• Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT

  6 months

• Protocol of TB-PET/CT in NPC

  6 months

Study Arms (1)

uEXPLORER total-body PET/CT

Newly diagnosed NPC patients will undergo a one-hour total-body dynamic PET/CT examination and subsequently followed by a conventional PET/CT scan within 30 minutes

Device: ultrasensitive positron emission tomography

Interventions

ultrasensitive positron emission tomography DEVICE

A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER)

Also known as: conventional PET/CT

uEXPLORER total-body PET/CT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

newly diagnosed NPC

You may qualify if:

• Patients must be informed of the investigational nature of this study and given written informed consent.
• Aged between 18-65, male/female.
• Histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III)..
• 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
• Patients with diabetes
• 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 (2)

• 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 BACKGROUND

• 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

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

Study Officials

• Haiqiang Mai, Dr

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

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: June 20, 2020
• Primary Completion: February 20, 2021
• Study Completion: June 20, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)