Perfusion and Hypoxia Evaluation in Tumors Using 18F-FDG PET/CT

February 20, 2020 updated by: Yingying Sun, Harbin Medical University

Tumor Perfusion and Hypoxia Evaluation and Comparation in 18F-FDG PET/CT

Investigators want to use 18F-FDG PET/CT imaging to reflect tumor perfusion and hypoxia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Perfusion and hypoxia were independent prognositic parameters for tumor patients. Developing a method that can evaluate tumor perfusion and hypoxia noninvasively and conveniently was in urgent need. 18F-FDG PET/CT imaging could reflect tumor hypoxia in 60min balanced imaging was proved and accepted. Moreover, FDG could diffuse out of the vasculature and through cell membranes passively and rapidly due to its lipophilicity, its regional uptake at initial times is expected to reflect tumor perfusion. So, investigators want to use 18F-FDG PET/CT imaging to evaluate tumor perfusion and hypoxia simutaniously，in order to guide the clinical diagnosis and treatment.

Study Type

Observational

Enrollment (Anticipated)

40

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
    • Heil
      • Harbin, Heil, China, 150028
        • Recruiting
        • Yingying Sun
        • Contact:

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tumor patients aged more than 18 years with a histological confirmed diagnosis were eligible in our research. And all patients signed a written informed consent.

Description

Inclusion Criteria:

  • 1.solid tumor proved by pathology(d>3.0cm);
  • 2.age>18-year-old;
  • 3. Karnofsky performance status >70;
  • 4.sign the informed consent.

Exclusion Criteria:

  • 1.There are obvious metal implants near the tumor;
  • 2.Can not lie still for 15 minutes.
  • 3.Pregnancy.

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
18F-FDG PET/CT initial-time imaging
PET/CT imaging was underwent 5min after 18F-FDG injection.
Diagnostic test: 18F-FDG PET/CT initial-time imaging
18F-FDG intravenous bolus injection after a fasting perid of more than 6 hours, simultaneously,PET/CT imaging using one bed lasting 5 minutes was underwent.
18F-FDG PET/CT balanced-time imaging
PET/CT imaging was underwent 60min after 18F-FDG injection.
Diagnostic test: 18F-FDG PET/CT balanced-time imaging
18F-FDG intravenous injection after a fasting perid of more than 6 hours. After 60 minutes, PET/CT imaging using 6-7 bed positions each lasting 2 minutes was underwent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the distribution of FDG between initial-time and balanced-time PET/CT
Time Frame: 2018.1
Initial-time and balanced-time PET/CT imaging were registrated using PET/CT Compare software in GE AW4.6 workstation. FDG distribution was evaluated in each imaging and the correlation was evaluated.
2018.1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVs in initial-time and balanced-time PET/CT
Time Frame: 2018.1
the SUVmax and SUVmean was calculated in well-perfused area and hypoxia area in tumors using PET/CT Render software in GE AW4.6 workstation.
2018.1

Collaborators and Investigators

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

Sponsor

Harbin Medical University

Investigators

  • Study Chair: Baozhong Shen, Dr, The Fourth Hospital of Harbin Medical University

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)

November 1, 2016

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14008 (Company Internal)

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

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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