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

Sponsor
Harbin Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03373994
Collaborator
(none)
40
Enrollment
1
Location
50
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 18F-FDG PET/CT initial-time imaging
  • Diagnostic Test: 18F-FDG PET/CT balanced-time imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tumor Perfusion and Hypoxia Evaluation and Comparation in 18F-FDG PET/CT
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Correlation of the distribution of FDG between initial-time and balanced-time PET/CT [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

  1. SUVs in initial-time and balanced-time PET/CT [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 1.solid tumor proved by pathology(d>3.0cm);

  • 2.age>18-year-old;

    1. 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

Locations

Site City State Country Postal Code
1 Yingying Sun Harbin Heil China 150028

Sponsors and Collaborators

  • Harbin Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yingying Sun, Attending physician， doctor, Harbin Medical University
ClinicalTrials.gov Identifier:
NCT03373994
Other Study ID Numbers:
  • 14008
First Posted:
Dec 14, 2017
Last Update Posted:
Feb 21, 2020
Last Verified:
Feb 1, 2020
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:
No
Keywords provided by Yingying Sun, Attending physician， doctor, Harbin Medical University
FDG, perfusion, hypoxia, tumor, PET
Additional relevant MeSH terms:
Hypoxia
Fluorodeoxyglucose F18

Study Results

No Results Posted as of Feb 21, 2020