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Trial record 3 of 261469 for:    ALL

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

This study is currently recruiting participants.
Verified December 2017 by Yingying Sun, Harbin Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03373994
First Posted: December 14, 2017
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yingying Sun, Harbin Medical University
  Purpose
Investigators want to use 18F-FDG PET/CT imaging to reflect tumor perfusion and hypoxia.

Condition Intervention
Perfusion and Hypoxia Diagnostic Test: 18F-FDG PET/CT initial-time imaging Diagnostic Test: 18F-FDG PET/CT balanced-time imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tumor Perfusion and Hypoxia Evaluation and Comparation in 18F-FDG PET/CT

Resource links provided by NLM:


Further study details as provided by Yingying Sun, Harbin Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Actual Study Start Date: November 1, 2016
Estimated Study Completion Date: January 31, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373994


Contacts
Contact: Yingying Sun, Dr 13936447513 505679386@qq.com

Locations
China, Heil
Yingying Sun Recruiting
Harbin, Heil, China, 150028
Contact: Yingying Sun, Dr    13936447513    505679386@qq.com   
Sponsors and Collaborators
Harbin Medical University
Investigators
Study Chair: Baozhong Shen, Dr The Fourth Hospital of Harbin Medical University
  More Information

Responsible Party: Yingying Sun, The forth hospital of Harbin Medical University, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03373994     History of Changes
Other Study ID Numbers: 14008
First Submitted: December 4, 2017
First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yingying Sun, Harbin Medical University:
FDG, perfusion, hypoxia, tumor, PET

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action