GliomaNCT03102203
Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Clinical Trial With Multimodality MR Imaging
An observational study of Glioma, run by Jinling Hospital, China at 1 site in China.
Trial summary
To evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the establishment of new diagnostic criteria for the identification of true and pseudoprogression of high-grade gliomas. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2016to Dec 2018
- 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: The Eligibility module specifies the criteria for determining which people are (or are not) eligible to participate in the study
Who may be able to join
- Patients with high-grade gliomas confirmed by pathology and have not been treated with concurrent chemoradiotherapy;
- Written informed consent is obtained.
Who cannot join
- Patients not suitable for enhanced MRI scanning of patients;
- Patients who have not finished follow-up concurrent chemoradiotherapy or MR scanning.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Zhiqiang Zhang, Doctor, +86 13913885490, zhangzq2001@126.com
About this study
Official title: Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Prospective Multicenter Clinical Trial With Multimodality MR Imaging
To evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the establishment of new diagnostic criteria for the identification of true and pseudoprogression of high-grade gliomas.
- Conditions
- Glioma
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Ktrans
The volume transfer constant in dynamic contrast-enhanced MR Imaging
Measured: baseline
Ktrans
The volume transfer constant in dynamic contrast-enhanced MR Imaging
Measured: 3 months
Ktrans
The volume transfer constant in dynamic contrast-enhanced MR Imaging
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start8 Jun 2016
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Guang Ming, Jinling Hospital, China
- Investigators
- Guang Ming Lu, Doctor, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102203
- Sponsor's protocol ID
- NanjingJH01
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2017
- Last updated
- 5 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation of Progression From Treatment Effects in High-Grade Gliomas: A Prospective Multicenter Clinical Trial With Multimodality MR Imaging
- ClinicalTrials.gov ID
- NCT03102203
- Acronym / sponsor ID
- NanjingJH01
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Apr 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.
To evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the establishment of new diagnostic criteria for the identification of true and pseudoprogression of high-grade gliomas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Eligibility module specifies the criteria for determining which people are (or are not) eligible to participate in the study
Key inclusion criteria (2 listed)
- Patients with high-grade gliomas confirmed by pathology and have not been treated with concurrent chemoradiotherapy;
- Written informed consent is obtained.
Key exclusion criteria (2 listed)
- Patients not suitable for enhanced MRI scanning of patients;
- Patients who have not finished follow-up concurrent chemoradiotherapy or MR scanning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ktrans
Time frame: baseline
The volume transfer constant in dynamic contrast-enhanced MR Imaging
Ktrans
Time frame: 3 months
The volume transfer constant in dynamic contrast-enhanced MR Imaging
Ktrans
Time frame: 10 months
The volume transfer constant in dynamic contrast-enhanced MR Imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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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.
Guang Ming Lu, Doctor principal investigator
Jinling Hospital, China
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 Glioma, run by Jinling Hospital, China 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 2 inclusion and 2 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 5 Apr 2017. 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 Yuan Xie, Master (+86 13584099838, cheryl050914@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ktrans (time frame: baseline). The study lists 3 primary outcomes in all. 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 5 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.