GliomaNCT06018870
MRI Contrast Clearance Analysis for Glioma Grading and Genotyping
An observational study of Glioma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Gliomas are the most common primary brain tumor. Gliomas with different grades have different clinical behaviors that determine treatment planning and patient prognosis in clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects are not restricted by gender and age. For details, please refer to the "criteria" column.
Who may be able to join
- Patients with brain space -occupying lesions, have not yet undergone antitumor therapy;
- MRI with T1-contract delayed sequence was performed less than 2 weeks before surgery;
- Definite histopathologic diagnosis of glioma.
Who cannot join
- WHO 1 gliomas and other non-glioma brain tumors;
- Poor image quality and heavy artifact affect the subsequent image processing.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sang Zifan
Chongqing, Chongqing Municipality, 400042
Zifan Sang, M.M, +8618379873389, 952034224@qq.com
About this study
Official title: MRI Contrast Clearance Analysis for Prediction of Grading and Genotyping in Gliomas
Gliomas are the most common primary brain tumor. Gliomas with different grades have different clinical behaviors that determine treatment planning and patient prognosis in clinical practice. In the 2021 World Health Organization (WHO) classification of tumors for the central nervous system, glioma genotyping was considered the most relevant information for neuroradiologists. The isocitrate dehydrogenase (IDH) genotype and 1p/19q codeletion status are two essential molecular markers that divide glioma into three groups: IDH wild-type, IDH mutant with 1p/19q non-codeletion, and IDH mutant with 1p/19q codeletion.
MRI contrast clearance analysis (CCA) is based on T1 delayed-contrast subtraction map, Blue/tumor regions in CCA represent efficient clearance of contrast from the tissue (delayed signal<early signal), while red/nontumor regions in CCA represent contrast accumulation (delayed signal>early signal).
However, there are not any reports on the role of MRI CCA in glioma grading and genotyping, Thus, We hypothesized that the proportion of blue/red region and their histogram analyses, which could be acquired for predicting IDH genotypes and 1p/19q codeletion in gliomas, and to assess the application of CCA in glioma grading.
Read the detailed description
This is a single-center bidirectional cohort study. The subjects of this study were patients diagnosed as glioma by pathological biopsy. Patients with suspicious mass will be performed extra 30 and 60 min after contrast agent application delayed T1-weighted sequences as same as before. Then enter the next experimental stage. (1) Image format conversion; (2) Registration;(3) Subtraction;(4) ROI segmentation;(5) ROI histogram analyses. Histogram parameters of blue and red ROI includes 1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.
Finally, statistical methods were used to determine whether those parameters was statistically significant for IDH mutation status、1p/19q codeletion status and tumor grading.
- Conditions
- Glioma
- Keywords
- Glioma
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of bule/red ROI
The common vessels morphology in the blue region was undamaged vessel lumens which exists in active tumor, while vessels in the red regions presented different stages of vessel necrosis.
Measured: Through study completion, an average of 1 year
Histogram of bule/red ROI
The bule and red ROI from CCA histogram analysis included1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiguo Zhang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018870
- Sponsor's protocol ID
- 2023183
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Contrast Clearance Analysis for Prediction of Grading and Genotyping in Gliomas
- ClinicalTrials.gov ID
- NCT06018870
- Acronym / sponsor ID
- 2023183
- Conditions
- Glioma
- Keywords
- Glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 31 Aug 2023 (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.
Gliomas are the most common primary brain tumor. Gliomas with different grades have different clinical behaviors that determine treatment planning and patient prognosis in clinical practice. In the 2021 World Health Organization (WHO) classification of tumors for the central nervous system, glioma genotyping was considered the most relevant information for neuroradiologists. The isocitrate dehydrogenase (IDH) genotype and 1p/19q codeletion status are two essential molecular markers that divide glioma into three groups: IDH wild-type, IDH mutant with 1p/19q non-codeletion, and IDH mutant with 1p/19q codeletion.
MRI contrast clearance analysis (CCA) is based on T1 delayed-contrast subtraction map, Blue/tumor regions in CCA represent efficient clearance of contrast from the tissue (delayed signal<early signal), while red/nontumor regions in CCA represent contrast accumulation (delayed signal>early signal).
However, there are not any reports on the role of MRI CCA in glioma grading and genotyping, Thus, We hypothesized that the proportion of blue/red region and their histogram analyses, which could be acquired for predicting IDH genotypes and 1p/19q codeletion in gliomas, and to assess the application of CCA in glioma grading.
Detailed description
This is a single-center bidirectional cohort study. The subjects of this study were patients diagnosed as glioma by pathological biopsy. Patients with suspicious mass will be performed extra 30 and 60 min after contrast agent application delayed T1-weighted sequences as same as before. Then enter the next experimental stage. (1) Image format conversion; (2) Registration;(3) Subtraction;(4) ROI segmentation;(5) ROI histogram analyses. Histogram parameters of blue and red ROI includes 1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.
Finally, statistical methods were used to determine whether those parameters was statistically significant for IDH mutation status、1p/19q codeletion status and tumor grading.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects are not restricted by gender and age. For details, please refer to the "criteria" column.
Key inclusion criteria (3 listed)
- Patients with brain space -occupying lesions, have not yet undergone antitumor therapy;
- MRI with T1-contract delayed sequence was performed less than 2 weeks before surgery;
- Definite histopathologic diagnosis of glioma.
Key exclusion criteria (2 listed)
- WHO 1 gliomas and other non-glioma brain tumors;
- Poor image quality and heavy artifact affect the subsequent image processing.
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
Proportion of bule/red ROI
Time frame: Through study completion, an average of 1 year
The common vessels morphology in the blue region was undamaged vessel lumens which exists in active tumor, while vessels in the red regions presented different stages of vessel necrosis.
Histogram of bule/red ROI
Time frame: Through study completion, an average of 1 year
The bule and red ROI from CCA histogram analysis included1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
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.
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 Daping Hospital and the Research Institute of Surgery of the Third Military 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 3 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 31 Aug 2023. 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 Zifan Sang, M.M (+8618379873389, 952034224@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of bule/red ROI (time frame: Through study completion, an average of 1 year). The study lists 2 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 31 Aug 2023.