GliomaNCT04407039
Establishment and Evaluation of Multimodal Image Recognition System of Glioma Based on Deep Learning
An observational study of Glioma, run by Tao Xin.
Trial summary
Research purposes: 1. To obtain the metabolic characteristics of glioma molecular imaging through a multimodal image recognition system. 2. To determine whether molecular imaging metabolic parameters can characterize the molecular typing of glioma by analyzing the relationship between metabolic parameters and tumor… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma
- What is being tested?
- PET/CT, H-MRS and MRI
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2021to 30 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients from Shandong Province Qianfoshan Hospital
Who may be able to join
- glioma patients confirmed by postoperatively pathology ;
- the lesion is non-diffuse, and the tumor body, edema and surrounding normal tissue are clearly delimited;
- capacity to give informed consent and follow study procedures.
Who cannot join
- patients with previous treatment of glioma;
- lack of clinical and image data or data inability to meet research needs;
- severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification);
- patients who gave up halfway
About this study
Research purposes:
- To obtain the metabolic characteristics of glioma molecular imaging through a multimodal image recognition system.
- To determine whether molecular imaging metabolic parameters can characterize the molecular typing of glioma by analyzing the relationship between metabolic parameters and tumor subtypes
- To get metabolic classification based on metabolic parameters of glioma molecular imaging, and to identify the relationship between metabolic subtypes and surgical resection, radiotherapy and chemotherapy, and prognosis and further refine the molecular classification of glioma.
Read more
Research Background:
Glioma is the most common primary intracranial malignant tumor, accounting for 80% of central nervous system malignant tumors. It is highly invasive, with a surgical recurrence rate of up to 90%. The prognosis is extremely poor, which has caused a great burden. There are different molecular subtypes of glioma with distinct molecular biological characteristics, resulting in various prognosis of patients. With the continuous development of basic and clinical research of glioma and the advent of various new drugs and treatment technologies, molecular pathological diagnosis based on the individual level of glioma patients is particularly important. Clarifying the molecular pathology type before surgery will help the clinical diagnosis and prognostic judgment of glioma, and is of great significance for the optimization of treatment options.
Based on the establishment of glioma molecular typing system, the project team use noninvasive molecular imaging technology to clarify the characteristics of molecular subsets of glioma based on the tumor metabolic parameters. Through combining deep learning-based target detection and image recognition with big data analysis, it has great potential in the clinical research of glioma diagnosis, prognosis and treatment options, which could provide a scientific basis for the establishment and promotion of glioma molecular analysis and recognition system.
Read the detailed description
- Multimodal Image Recognition System of Glioma Molecular imaging is the use of imaging methods to display specific molecules at the tissue level, cellular level, and subcellular level, reflecting changes in the molecular level in the living state, and performing qualitative and quantitative researches on the biological behavior of the imaging aspect. Multimodal Image Recognition System includes Positron Emission Computed Tomography (PET), Magnetic Resonance Imaging (MRI) and Magnetic Resonance Hydrogen Proton Spectroscopy (1H-MRS). 1H-MRS quantifies the choline (Cho) and creatine (Cr) in the spectrum, N-acetylaspartate acid (NAA), qualification (Lip) and lactic acid (Lac) and other substances to reflect changes in cell metabolites, and then speculate on the occurrence and development of tumors. Imaging of the glucose analog 18F-labeled fluorodeoxyglucose (18FDG) by positron emission tomography (PET) is the gold standard for the assessment of cerebral glucose metabolism in vivo. However, single imaging method often has limitations, and it is difficult to meet the requirements for sensitivity, specificity, and target at the same time. Combing PET / CT with 1H- MRS of new generation imaging technologies can overcome the shortcomings of a single imaging method and achieve complementary advantages and provide effective informations
- Risks and Benefits of Participants (1) Risks: In addition to collecting information above, the main risk is discomfort that may occur during the conversation. Since this study will not intervene in routine diagnosis and treatment, there are no other special risks other than the possible discomfort and adverse reactions mentioned above expected during treatment. (2) Benefits: No direct benefits, but may provide useful informations for disease research.
- Statistical Methods All data (clinical data, imaging data) will be established in a special database. In order to control the imbalance of many different confounding factors in the formed population, the test will use the propensity score method to achieve the purpose of controlling confounding and improve the quality of real-world evidence, close to the effect of randomization.
- Criteria for aborting trials and ending clinical trials
- Criteria for aborting trials The investigator judges that continuing the trial is not good for the patient; During the course of the study, the patient is unwilling to continue the clinical study, and makes a withdrawal request to the competent doctor and requests to cancel the informed consent.
- Criteria for ending clinical research: If serious safety problems occur during the study, the study should be terminated in time; The ethics committee requested to terminate the trial after the study; The health administrative department ordered the termination of clinical research for some reason; Significant deviations have occurred in the design or implementation of the study protocol and it is difficult to evaluate the results.
- Participant's Code, Storage Procedure of Case Report, Data Management and Guarantee of Test Reliability
- After the participants enter the cohort after signing the informed consent, they will be sorted and assigned a serial number by the research secretary according to the time when the informed consent is signed. Therefore, the first patient enrolled is coded 001.
- The patient's case report form will be made into a special patient manual, which will be kept by the research secretary and clinical staff for data collection and follow-up. Any observations and inspection results during the test should be entered into the form and database in a timely, accurate, complete, clear, standardized, and true manner. After the subject's follow-up is over, hand over and perform data collection and analysis. The subject's imaging data will be regularly uploaded by the research secretary to the intelligent IT virtual storage system based on the cluster. The system divides neurosurgery and subjects into specific storage partitions.
- Each researcher has the authority to consult and modify the subject's storage partition. The storage system automatically records the changes of the stored data, thus ensuring the traceability of the data. The investigator should agree to keep all research data (including original records, informed consent of all patients, all case report forms, etc.), and the special counter shall be locked and stored until 5 years after the end of the trial.
- Safety
- Serious adverse event: death; medical personnel believe what is life-threatening; events requiring hospitalization or extension of hospital stay; persistent or severe disability or disability.
- Reporting methods and measures after the occurrence of the adverse events above, the medical staff should first report to the main investigator and fill out the adverse event report form. The adverse reaction report includes the diagnosis and treatment of the patient, the time of the event, the cause of the event and the treatment after the event. Provide timely diagnosis and treatment after serious adverse events, and report to the ethics committee within 24 hours. Report regularly according to the requirements of the ethics committee.
- Ethical requirements
- Follow the Declaration of Helsinki.
- Recruitment and informed process: The main investigator and his team members will recruit the subjects in the clinics or wards, inform the research content and related matters in detail, and read and sign the informed consent form before enrollment.
- All trials will be conducted after obtaining the approval of the Ethics Committee of Qian Foshan Hospital in Shandong Province as well as follow-up review.
- Conditions
- Glioma
- Being tested
- PET/CT, H-MRS and MRI
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT, H-MRS and MRIDevice
Use imaging methods to get metabolic parameters.
| Study group | Role | What they receive |
|---|---|---|
| Glioma molecular subtype: G-CIMP-low | one of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma Receives: Device: PET/CT, H-MRS and MRI | |
| Glioma molecular subtype: G-CIMP-high | one of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma Receives: Device: PET/CT, H-MRS and MRI | |
| Glioma molecular subtype: codel | one of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma Receives: Device: PET/CT, H-MRS and MRI | |
| Glioma molecular subtype: classic-like | one of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma Receives: Device: PET/CT, H-MRS and MRI | |
| Glioma molecular subtype: mesenchymal-like | one of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma Receives: Device: PET/CT, H-MRS and MRI | |
| Glioma molecular subtype: LGM6-GBM | one of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma Receives: Device: PET/CT, H-MRS and MRI | |
| Glioma molecular subtype: PA-like | one of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma Receives: Device: PET/CT, H-MRS and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The data of multimodal image recognition system
- Cho (mmol/kg), Cr (mmol/kg), NAA (mmol/kg), Cho/Cr, Cho/NAA and NAA/Cr values Record the Cho (mmol/kg), Cr (mmol/kg), NAA (mmol/kg), Cho/Cr, Cho/NAA and NAA/Cr values in the lesion area, and calculate the ratio (relative reference value) to the metabolites of the healthy brain tissue area, namely r Cho, r Cr, r NAA, r Cho/Cr, r Cho/NAA and r NAA/Cr.
- 18 F-FDG uptake values The uptake of 18 F-FDG was analyzed based on the anatomical morphology of the lesions provided by MRI images. Finally, according to the 18F-FDG uptake of the lesion, it is divided into 5 levels: level 1 is no intake, level 2 is slightly lower than the contralateral normal brain tissue, level 3 is similar to the contralateral normal brain tissue, and level 4 is the intake The degree is slightly higher than that of the contralateral normal brain tissue. Level 5 is the level of uptake significantly higher than that of the contralateral normal brain tissue.
Measured: one week
Molecular subsets in in diffuse gliomas
(1) G-CIMP-low; (2) G-CIMP-high; (3) codel; (4) classic-like; (5) mesenchymal-like; (6) LGM6-GBM; (7) PA-like
Measured: five months
Secondary outcomes (1)
Overall survival
Overall survival of glioma patients
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start30 Dec 2021 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Tao Xin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Xin, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407039
- Sponsor's protocol ID
- YXLL-KY-2020 (009)
- Status last verified
- Sep 2021
- First submitted
- 25 May 2020
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Ceccarelli M, Barthel FP, Malta TM, Sabedot TS, Salama SR, Murray BA, Morozova O, Newton Y, Radenbaugh A, Pagnotta SM, Anjum S, Wang J, Manyam G, Zoppoli P, Ling S, Rao AA, Grifford M, Cherniack AD, Zhang H, Poisson L, Carlotti CG Jr, Tirapelli DP, Rao A, Mikkelsen T, Lau CC, Yung WK, Rabadan R, Huse J, Brat DJ, Lehman NL, Barnholtz-Sloan JS, Zheng S, Hess K, Rao G, Meyerson M, Beroukhim R, Cooper L, Akbani R, Wrensch M, Haussler D, Aldape KD, Laird PW, Gutmann DH; TCGA Research Network; Noushmehr H, Iavarone A, Verhaak RG. Molecular Profiling Reveals Biologically Discrete Subsets and Pathways of Progression in Diffuse Glioma. Cell. 2016 Jan 28;164(3):550-63. doi: 10.1016/j.cell.2015.12.028.
PubMed 26824661Chaumeil MM, Lupo JM, Ronen SM. Magnetic Resonance (MR) Metabolic Imaging in Glioma. Brain Pathol. 2015 Nov;25(6):769-80. doi: 10.1111/bpa.12310.
PubMed 26526945la Fougere C, Suchorska B, Bartenstein P, Kreth FW, Tonn JC. Molecular imaging of gliomas with PET: opportunities and limitations. Neuro Oncol. 2011 Aug;13(8):806-19. doi: 10.1093/neuonc/nor054. Epub 2011 Jul 13.
PubMed 21757446
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Evaluation of Multimodal Image Recognition System of Glioma Based on Deep Learning
- ClinicalTrials.gov ID
- NCT04407039
- Acronym / sponsor ID
- YXLL-KY-2020 (009)
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Tao XinUniversity, hospital or other
- Study start
- 30 Dec 2021 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 May 2020 (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.
Research purposes:
- To obtain the metabolic characteristics of glioma molecular imaging through a multimodal image recognition system.
- To determine whether molecular imaging metabolic parameters can characterize the molecular typing of glioma by analyzing the relationship between metabolic parameters and tumor subtypes
- To get metabolic classification based on metabolic parameters of glioma molecular imaging, and to identify the relationship between metabolic subtypes and surgical resection, radiotherapy and chemotherapy, and prognosis and further refine the molecular classification of glioma.
Research Background:
Glioma is the most common primary intracranial malignant tumor, accounting for 80% of central nervous system malignant tumors. It is highly invasive, with a surgical recurrence rate of up to 90%. The prognosis is extremely poor, which has caused a great burden. There are different molecular subtypes of glioma with distinct molecular biological characteristics, resulting in various prognosis of patients. With the continuous development of basic and clinical research of glioma and the advent of various new drugs and treatment technologies, molecular pathological diagnosis based on the individual level of glioma patients is particularly important. Clarifying the molecular pathology type before surgery will help the clinical diagnosis and prognostic judgment of glioma, and is of great significance for the optimization of treatment options.
Based on the establishment of glioma molecular typing system, the project team use noninvasive molecular imaging technology to clarify the characteristics of molecular subsets of glioma based on the tumor metabolic parameters. Through combining deep learning-based target detection and image recognition with big data analysis, it has great potential in the clinical research of glioma diagnosis, prognosis and treatment options, which could provide a scientific basis for the establishment and promotion of glioma molecular analysis and recognition system.
Detailed description
- Multimodal Image Recognition System of Glioma Molecular imaging is the use of imaging methods to display specific molecules at the tissue level, cellular level, and subcellular level, reflecting changes in the molecular level in the living state, and performing qualitative and quantitative researches on the biological behavior of the imaging aspect. Multimodal Image Recognition System includes Positron Emission Computed Tomography (PET), Magnetic Resonance Imaging (MRI) and Magnetic Resonance Hydrogen Proton Spectroscopy (1H-MRS). 1H-MRS quantifies the choline (Cho) and creatine (Cr) in the spectrum, N-acetylaspartate acid (NAA), qualification (Lip) and lactic acid (Lac) and other substances to reflect changes in cell metabolites, and then speculate on the occurrence and development of tumors. Imaging of the glucose analog 18F-labeled fluorodeoxyglucose (18FDG) by positron emission tomography (PET) is the gold standard for the assessment of cerebral glucose metabolism in vivo. However, single imaging method often has limitations, and it is difficult to meet the requirements for sensitivity, specificity, and target at the same time. Combing PET / CT with 1H- MRS of new generation imaging technologies can overcome the shortcomings of a single imaging method and achieve complementary advantages and provide effective informations
- Risks and Benefits of Participants (1) Risks: In addition to collecting information above, the main risk is discomfort that may occur during the conversation. Since this study will not intervene in routine diagnosis and treatment, there are no other special risks other than the possible discomfort and adverse reactions mentioned above expected during treatment. (2) Benefits: No direct benefits, but may provide useful informations for disease research.
- Statistical Methods All data (clinical data, imaging data) will be established in a special database. In order to control the imbalance of many different confounding factors in the formed population, the test will use the propensity score method to achieve the purpose of controlling confounding and improve the quality of real-world evidence, close to the effect of randomization.
- Criteria for aborting trials and ending clinical trials
- Criteria for aborting trials The investigator judges that continuing the trial is not good for the patient; During the course of the study, the patient is unwilling to continue the clinical study, and makes a withdrawal request to the competent doctor and requests to cancel the informed consent.
- Criteria for ending clinical research: If serious safety problems occur during the study, the study should be terminated in time; The ethics committee requested to terminate the trial after the study; The health administrative department ordered the termination of clinical research for some reason; Significant deviations have occurred in the design or implementation of the study protocol and it is difficult to evaluate the results.
- Participant's Code, Storage Procedure of Case Report, Data Management and Guarantee of Test Reliability
- After the participants enter the cohort after signing the informed consent, they will be sorted and assigned a serial number by the research secretary according to the time when the informed consent is signed. Therefore, the first patient enrolled is coded 001.
- The patient's case report form will be made into a special patient manual, which will be kept by the research secretary and clinical staff for data collection and follow-up. Any observations and inspection results during the test should be entered into the form and database in a timely, accurate, complete, clear, standardized, and true manner. After the subject's follow-up is over, hand over and perform data collection and analysis. The subject's imaging data will be regularly uploaded by the research secretary to the intelligent IT virtual storage system based on the cluster. The system divides neurosurgery and subjects into specific storage partitions.
- Each researcher has the authority to consult and modify the subject's storage partition. The storage system automatically records the changes of the stored data, thus ensuring the traceability of the data. The investigator should agree to keep all research data (including original records, informed consent of all patients, all case report forms, etc.), and the special counter shall be locked and stored until 5 years after the end of the trial.
- Safety
- Serious adverse event: death; medical personnel believe what is life-threatening; events requiring hospitalization or extension of hospital stay; persistent or severe disability or disability.
- Reporting methods and measures after the occurrence of the adverse events above, the medical staff should first report to the main investigator and fill out the adverse event report form. The adverse reaction report includes the diagnosis and treatment of the patient, the time of the event, the cause of the event and the treatment after the event. Provide timely diagnosis and treatment after serious adverse events, and report to the ethics committee within 24 hours. Report regularly according to the requirements of the ethics committee.
- Ethical requirements
- Follow the Declaration of Helsinki.
- Recruitment and informed process: The main investigator and his team members will recruit the subjects in the clinics or wards, inform the research content and related matters in detail, and read and sign the informed consent form before enrollment.
- All trials will be conducted after obtaining the approval of the Ethics Committee of Qian Foshan Hospital in Shandong Province as well as follow-up review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Glioma molecular subtype: G-CIMP-low | – | Device: PET/CT, H-MRS and MRIone of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma |
| Glioma molecular subtype: G-CIMP-high | – | Device: PET/CT, H-MRS and MRIone of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma |
| Glioma molecular subtype: codel | – | Device: PET/CT, H-MRS and MRIone of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma |
| Glioma molecular subtype: classic-like | – | Device: PET/CT, H-MRS and MRIone of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma |
| Glioma molecular subtype: mesenchymal-like | – | Device: PET/CT, H-MRS and MRIone of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma |
| Glioma molecular subtype: LGM6-GBM | – | Device: PET/CT, H-MRS and MRIone of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma |
| Glioma molecular subtype: PA-like | – | Device: PET/CT, H-MRS and MRIone of molecular subtypes according to gene expression, DNA copy number, DNA methylation, exome sequencing and protein expression of glioma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients from Shandong Province Qianfoshan Hospital
Key inclusion criteria (3 listed)
- glioma patients confirmed by postoperatively pathology ;
- the lesion is non-diffuse, and the tumor body, edema and surrounding normal tissue are clearly delimited;
- capacity to give informed consent and follow study procedures.
Key exclusion criteria (4 listed)
- patients with previous treatment of glioma;
- lack of clinical and image data or data inability to meet research needs;
- severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification);
- patients who gave up halfway
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 |
|---|---|---|
| PET/CT, H-MRS and MRIUse imaging methods to get metabolic parameters. | Device | Glioma molecular subtype: G-CIMP-high, Glioma molecular subtype: G-CIMP-low, Glioma molecular subtype: LGM6-GBM, Glioma molecular subtype: PA-like, Glioma molecular subtype: classic-like, Glioma molecular subtype: codel, Glioma molecular subtype: mesenchymal-like |
Primary outcome
The data of multimodal image recognition system
Time frame: one week
1. Cho (mmol/kg), Cr (mmol/kg), NAA (mmol/kg), Cho/Cr, Cho/NAA and NAA/Cr values Record the Cho (mmol/kg), Cr (mmol/kg), NAA (mmol/kg), Cho/Cr, Cho/NAA and NAA/Cr values in the lesion area, and calculate the ratio (relative reference value) to the metabolites of the healthy brain tissue area, namely r Cho, r Cr, r NAA, r Cho/Cr, r Cho/NAA and r NAA/Cr. 2. 18 F-FDG uptake values The uptake of 18 F-FDG was analyzed based on the anatomical morphology of the lesions provided by MRI images. Finally, according to the 18F-FDG uptake of the lesion, it is divided into 5 levels: level 1 is no intake, level 2 is slightly lower than the contralateral normal brain tissue, level 3 is similar to the contralateral normal brain tissue, and level 4 is the intake The degree is slightly higher than that of the contralateral normal brain tissue. Level 5 is the level of uptake significantly higher than that of the contralateral normal brain tissue.
Molecular subsets in in diffuse gliomas
Time frame: five months
(1) G-CIMP-low; (2) G-CIMP-high; (3) codel; (4) classic-like; (5) mesenchymal-like; (6) LGM6-GBM; (7) PA-like
1 secondary outcome
Overall survival
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Background: PubMed 26824661Ceccarelli M, Barthel FP, Malta TM, Sabedot TS, Salama SR, Murray BA, Morozova O, Newton Y, Radenbaugh A, Pagnotta SM, Anjum S, Wang J, Manyam G, Zoppoli P, Ling S, Rao AA, Grifford M, Cherniack AD, Zhang H, Poisson L, Carlotti CG Jr, Tirapelli DP, Rao A, Mikkelsen T, Lau CC, Yung WK, Rabadan R, Huse J, Brat DJ, Lehman NL, Barnholtz-Sloan JS, Zheng S, Hess K, Rao G, Meyerson M, Beroukhim R, Cooper L, Akbani R, Wrensch M, Haussler D, Aldape KD, Laird PW, Gutmann DH; TCGA Research Network; Noushmehr H, Iavarone A, Verhaak RG. Molecular Profiling Reveals Biologically Discrete Subsets and Pathways of Progression in Diffuse Glioma. Cell. 2016 Jan 28;164(3):550-63. doi: 10.1016/j.cell.2015.12.028.
- Background: PubMed 26526945Chaumeil MM, Lupo JM, Ronen SM. Magnetic Resonance (MR) Metabolic Imaging in Glioma. Brain Pathol. 2015 Nov;25(6):769-80. doi: 10.1111/bpa.12310.
- Background: PubMed 21757446la Fougere C, Suchorska B, Bartenstein P, Kreth FW, Tonn JC. Molecular imaging of gliomas with PET: opportunities and limitations. Neuro Oncol. 2011 Aug;13(8):806-19. doi: 10.1093/neuonc/nor054. Epub 2011 Jul 13.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Tao Xin.
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 4 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The data of multimodal image recognition system (time frame: one week). 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?
On the ClinicalTrials.gov record for NCT04407039, which also lists 4 linked publications.
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 9 Sep 2021.