Perfusion and HypoxiaNCT03373994
Perfusion and Hypoxia Evaluation in Tumors Using 18F-FDG PET/CT
An observational study of Perfusion and Hypoxia, run by Harbin Medical University at 1 site in China.
Trial summary
Investigators want to use 18F-FDG PET/CT imaging to reflect tumor perfusion and hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perfusion and Hypoxia
- What is being tested?
- 18F-FDG PET/CT initial-time imaging and 18F-FDG PET/CT balanced-time imaging
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1.solid tumor proved by pathology(d>3.0cm);
- 2.age>18-year-old;
- 3. Karnofsky performance status >70;
- 4.sign the informed consent.
Who cannot join
- 1.There are obvious metal implants near the tumor;
- 2.Can not lie still for 15 minutes.
- 3.Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yingying Sun
Harbin, Heil, 150028
Yingying Sun, Dr, 13936447513, 505679386@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Perfusion and Hypoxia
- Being tested
- 18F-FDG PET/CT initial-time imaging, 18F-FDG PET/CT balanced-time imaging
- Keywords
- FDG, perfusion, hypoxia, tumor, PET
- Medical subject headings
- Hypoxia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CT initial-time imagingDiagnostic test
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 imagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG PET/CT initial-time imaging | PET/CT imaging was underwent 5min after 18F-FDG injection. Receives: Diagnostic Test: 18F-FDG PET/CT initial-time imaging | |
| 18F-FDG PET/CT balanced-time imaging | PET/CT imaging was underwent 60min after 18F-FDG injection. Receives: Diagnostic Test: 18F-FDG PET/CT balanced-time imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2018.1
Secondary outcomes (1)
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.
Measured: 2018.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Nov 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion and HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingying Sun, Harbin Medical University
- Investigators
- Baozhong Shen, Dr, Study chair, The Fourth Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373994
- Sponsor's protocol ID
- 14008
- Status last verified
- Feb 2020
- First submitted
- 4 Dec 2017
- Last updated
- 21 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Perfusion and Hypoxia Evaluation and Comparation in 18F-FDG PET/CT
- ClinicalTrials.gov ID
- NCT03373994
- Acronym / sponsor ID
- 14008
- Conditions
- Perfusion and Hypoxia
- Keywords
- FDG, perfusion, hypoxia, tumor, PET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators want to use 18F-FDG PET/CT imaging to reflect tumor perfusion and hypoxia.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG PET/CT initial-time imaging | – | Diagnostic Test: 18F-FDG PET/CT initial-time imagingPET/CT imaging was underwent 5min after 18F-FDG injection. |
| 18F-FDG PET/CT balanced-time imaging | – | Diagnostic Test: 18F-FDG PET/CT balanced-time imagingPET/CT imaging was underwent 60min after 18F-FDG injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 1.solid tumor proved by pathology(d>3.0cm);
- 2.age>18-year-old;
- 3. Karnofsky performance status >70;
- 4.sign the informed consent.
Key exclusion criteria (3 listed)
- 1.There are obvious metal implants near the tumor;
- 2.Can not lie still for 15 minutes.
- 3.Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CT initial-time imaging18F-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. | Diagnostic test | 18F-FDG PET/CT initial-time imaging |
| 18F-FDG PET/CT balanced-time imaging18F-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. | Diagnostic test | 18F-FDG PET/CT balanced-time imaging |
Primary outcome
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.
1 secondary outcome
SUVs in initial-time and balanced-time PET/CT
Time frame: 2018.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baozhong Shen, Dr study chair
The Fourth Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perfusion and Hypoxia, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingying Sun, Dr (13936447513, 505679386@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the distribution of FDG between initial-time and balanced-time PET/CT (time frame: 2018.1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.