uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma

September 12, 2021 updated by: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Potential of uEXPLORER Total-body PET/CT in Nasopharyngeal Carcinoma: The Dynamic Imaging, Kinetic Parameters, and Comparison With Conventional PET/CT

uEXPLORER total-body PET/CT in Nasopharyngeal Carcinoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

newly diagnosed NPC

Description

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 ≥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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The results of uEXPLORER Total-body PET/CT
Time Frame: 6 months
The Dynamic Imaging, Kinetic Parameters of uEXPLORER Total-body PET/CT
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of uEXPLORER Total-body PET/CT and Conventional PET/CT
Time Frame: 6 months
Image quality and Static Lesion detectability of TB-PET/CT and conventional PET/CT
6 months
Protocol of TB-PET/CT in NPC
Time Frame: 6 months
Acquisition time and low dose simulation of TB-PET/CT
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2020

Primary Completion (Actual)

February 20, 2021

Study Completion (Actual)

June 20, 2021

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-5-13 high-sensitivity PET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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