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uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT04394065
Collaborator
(none)
56
Enrollment
1
Location
12
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

Condition or Disease Intervention/Treatment Phase
  • Device: ultrasensitive positron emission tomography

Detailed Description

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. The objective of this study is to determine its specific effect in newly diagnosed nasopharyngeal carcinoma compared with conventional PET/CT and the quantitative kinetic parameters including glucose metabolic rate (Ki), glucose transport rate of flow-in (k1) and flow-out (k2) between tissue and blood, and glucosamine-6-phosphatization rate in tissue (k3). All the neck lymph nodes suspected for metastatic in PET/CT were biopsied under the guidance of ultrasound for a pathological diagnosis.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
56 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Potential of uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma: The Dynamic Imaging, Kinetic Parameters, and Comparison With Conventional PET/CT
Actual Study Start Date :
Jun 20, 2020
Actual Primary Completion Date :
Feb 20, 2021
Actual Study Completion Date :
Jun 20, 2021

Arms and Interventions

Arm Intervention/Treatment
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
A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER)
Other Names:
  • conventional PET/CT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The results of uEXPLORER Total-body PET/CT [6 months]

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

    Secondary Outcome Measures

    1. Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT [6 months]

      Image quality and Static Lesion detectability of TB-PET/CT and conventional PET/CT

    2. Protocol of TB-PET/CT in NPC [6 months]

      Acquisition time and low dose simulation of TB-PET/CT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 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 ≥4109/L , PLT ≥100109/L,

    • With normal liver function test (ALT and AST ≤2.5ULN, TBil ≤2.0ULN)

    • With normal renal function test (serum creatinine ≤1.5*ULN)

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Haiqiang Mai, Dr, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hai-Qiang Mai,MD,PhD, Chief Physician, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04394065
    Other Study ID Numbers:
    • 2020-5-13 high-sensitivity PET
    First Posted:
    May 19, 2020
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Hai-Qiang Mai,MD,PhD, Chief Physician, Sun Yat-sen University
    ultrasensitive PET CT
    Additional relevant MeSH terms:
    Carcinoma
    Nasopharyngeal Carcinoma

    Study Results

    No Results Posted as of Sep 17, 2021