GliomaNCT02622620
Study on Neuroepithelial Tumor Grading and Pseudoprogression After Glioma Therapy Using Advanced Functional MRI Techniques
An observational study of Glioma and Neoplasms, run by Tang-Du Hospital.
Trial summary
Contrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading and monitoring for tumor recurrence,but the ability to predict tumor behavior remains very limited.In this study, the investigators will use multi-b-value diffusion-weighted imaging(DWI),three-dimensional arterial spin… Read more about this study
- Who is it for?
- Any age
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide
Who may be able to join
- Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.
Who cannot join
- Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients do not show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.
About this study
Contrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading and monitoring for tumor recurrence,but the ability to predict tumor behavior remains very limited.In this study, the investigators will use multi-b-value diffusion-weighted imaging(DWI),three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced MRI imaging(DCE) to evaluate neuroepithelial tumor grading and monitor for tumor recurrence.
Read the detailed description
Glioma is classified into 4 grades, with worse prognosis for more advanced grades.Previous studies have suggested that different therapeutic strategies should be applied for gliomas at different grades,so glioma grading before the operation is therefore of important clinical significance for guiding the grade-dependent therapeutic strategy.
Combination temozolomide and radiation significantly prolongs survival compared with radiation alone and has become standard treatment for Patients with high-grade glioma. Response assessment in these patients is difficult as a result of the frequent occurrence of early imaging changes indistinguishable from tumor progression, termed pseudoprogression. The majority of patients remain clinically stable. It is often unclear whether current therapy should be maintained or second-line therapy initiated.
The ADC value can potentially reveal the differences in cellularity and nuclear atypia of gliomas1. Theoretically, high cellularity in advanced gliomas may impede free water diffusion and thus lead to a decreased ADC value.In several previous studies,recurrent tumors have shows significantly higher cellularity than those shown by pseudoprogression.Such high cellularity is associated with relative reductions in extracellular space when compared with low cellularity, resulting in decreased diffusivity of water molecules in the former circumstance when compared with the latter. DWI measures the degree of water diffusion within tissue Apparent diffusion coefficient (ADC) values quantify the mobility of water molecules at the cellular level, holding the potential to differentiate between necrosis, edema and recurrent tumor.
A potential mechanism of pseudoprogression is that radiation-induced vascular changes may lead to focal transient increase in gadolinium enhancement.Three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced (DCE) MRI imaging provides a noninvasive means for quantifying tumor vascular properties.
- Keywords
- dynamic contrast-enhanced MR imaging, three-dimensional arterial spin labeling, diffusion-weighted imaging
- Medical subject headings
- Glioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with glioma | Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To prospectively acquire multiparameter MR variables at 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and pseudoprogression as established by pathologic examination
Measured: 24 months
Secondary outcomes (1)
To compare the predictive values of the multiparameter MR tissue signatures acquired at 3T
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startJul 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622620
- Sponsor's protocol ID
- 2014JZ2-007
- Status last verified
- Mar 2016
- First submitted
- 18 Nov 2015
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yan LF, Sun YZ, Zhao SS, Hu YC, Han Y, Li G, Zhang X, Tian Q, Liu ZC, Yang Y, Nan HY, Yu Y, Sun Q, Zhang J, Chen P, Hu B, Li F, Han TH, Wang W, Cui GB. Perfusion, Diffusion, Or Brain Tumor Barrier Integrity: Which Represents The Glioma Features Best? Cancer Manag Res. 2019 Nov 27;11:9989-10000. doi: 10.2147/CMAR.S197839. eCollection 2019.
PubMed 31819632Liu ZC, Yan LF, Hu YC, Sun YZ, Tian Q, Nan HY, Yu Y, Sun Q, Wang W, Cui GB. Combination of IVIM-DWI and 3D-ASL for differentiating true progression from pseudoprogression of Glioblastoma multiforme after concurrent chemoradiotherapy: study protocol of a prospective diagnostic trial. BMC Med Imaging. 2017 Feb 1;17(1):10. doi: 10.1186/s12880-017-0183-y.
PubMed 28143434
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Neuroepithelial Tumor Grading and Pseudoprogression After Glioma Therapy Using Advanced Functional MRI Techniques
- ClinicalTrials.gov ID
- NCT02622620
- Acronym / sponsor ID
- 2014JZ2-007
- Keywords
- dynamic contrast-enhanced MR imaging, three-dimensional arterial spin labeling, diffusion-weighted imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 4 Dec 2015 (estimated)
- 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.
Contrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading and monitoring for tumor recurrence,but the ability to predict tumor behavior remains very limited.In this study, the investigators will use multi-b-value diffusion-weighted imaging(DWI),three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced MRI imaging(DCE) to evaluate neuroepithelial tumor grading and monitor for tumor recurrence.
Detailed description
Glioma is classified into 4 grades, with worse prognosis for more advanced grades.Previous studies have suggested that different therapeutic strategies should be applied for gliomas at different grades,so glioma grading before the operation is therefore of important clinical significance for guiding the grade-dependent therapeutic strategy.
Combination temozolomide and radiation significantly prolongs survival compared with radiation alone and has become standard treatment for Patients with high-grade glioma. Response assessment in these patients is difficult as a result of the frequent occurrence of early imaging changes indistinguishable from tumor progression, termed pseudoprogression. The majority of patients remain clinically stable. It is often unclear whether current therapy should be maintained or second-line therapy initiated.
The ADC value can potentially reveal the differences in cellularity and nuclear atypia of gliomas1. Theoretically, high cellularity in advanced gliomas may impede free water diffusion and thus lead to a decreased ADC value.In several previous studies,recurrent tumors have shows significantly higher cellularity than those shown by pseudoprogression.Such high cellularity is associated with relative reductions in extracellular space when compared with low cellularity, resulting in decreased diffusivity of water molecules in the former circumstance when compared with the latter. DWI measures the degree of water diffusion within tissue Apparent diffusion coefficient (ADC) values quantify the mobility of water molecules at the cellular level, holding the potential to differentiate between necrosis, edema and recurrent tumor.
A potential mechanism of pseudoprogression is that radiation-induced vascular changes may lead to focal transient increase in gadolinium enhancement.Three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced (DCE) MRI imaging provides a noninvasive means for quantifying tumor vascular properties.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with glioma | – | –Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide
Key inclusion criteria (1 listed)
- Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.
Key exclusion criteria (1 listed)
- Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients do not show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.
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
To prospectively acquire multiparameter MR variables at 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and pseudoprogression as established by pathologic examination
Time frame: 24 months
1 secondary outcome
To compare the predictive values of the multiparameter MR tissue signatures acquired at 3T
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Derived from this study: PubMed 31819632Yan LF, Sun YZ, Zhao SS, Hu YC, Han Y, Li G, Zhang X, Tian Q, Liu ZC, Yang Y, Nan HY, Yu Y, Sun Q, Zhang J, Chen P, Hu B, Li F, Han TH, Wang W, Cui GB. Perfusion, Diffusion, Or Brain Tumor Barrier Integrity: Which Represents The Glioma Features Best? Cancer Manag Res. 2019 Nov 27;11:9989-10000. doi: 10.2147/CMAR.S197839. eCollection 2019.
- Derived from this study: PubMed 28143434Liu ZC, Yan LF, Hu YC, Sun YZ, Tian Q, Nan HY, Yu Y, Sun Q, Wang W, Cui GB. Combination of IVIM-DWI and 3D-ASL for differentiating true progression from pseudoprogression of Glioblastoma multiforme after concurrent chemoradiotherapy: study protocol of a prospective diagnostic trial. BMC Med Imaging. 2017 Feb 1;17(1):10. doi: 10.1186/s12880-017-0183-y.
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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 and Neoplasms, run by Tang-Du Hospital.
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 1 inclusion and 1 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 29 Mar 2016. 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?
To prospectively acquire multiparameter MR variables at 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and pseudoprogression as established by pathologic examination (time frame: 24 months). 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 NCT02622620, which also lists 2 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 29 Mar 2016.