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

Perfusion and Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03373994
• Other study ID #: 14008
• Status: Recruiting
• Start date: November 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Harbin Medical University
• Contact: Yingying Sun, Dr
• Phone: 13936447513
• Email: 505679386[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Perfusion and Hypoxia

Intervention

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
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.

Locations

Country	Name	City	State
China	Yingying Sun	Harbin	Heil

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the distribution of FDG between initial-time and balanced-time PET/CT	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	SUVs in initial-time and balanced-time PET/CT	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