Adult GlioblastomaNCT02613988
Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas
A study testing 3 Tesla magnetic resonance imaging, Chemical exchange saturation transfer MRI and Diffusion weighted MRI in people with Adult Glioblastoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This clinical trial studies advanced MR imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Glioblastoma
- What is being tested?
- 3 Tesla magnetic resonance imaging, Chemical exchange saturation transfer MRI and Diffusion weighted MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2020to Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma
- Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter
- Life expectancy of greater than 3 months
- Patients scheduled for standard therapy (6 weeks radiation treatment (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week RT, and followed routine monthly temozolomide therapy)
- Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Who cannot join
- Patients who underwent complete resection
- Patients with no evidence of measurable disease after surgery
- Patients who have had chemotherapy or radiotherapy
- Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
- Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
- For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas
This clinical trial studies advanced MR imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas.
Read the detailed description
The standard care of patients with glioblastoma is concomitant chemoradiation and adjuvant temozolomide. Allowing for assessment of tumor therapy prior to treatment completion is important to select patients most likely to benefit from alternative treatment option. Multimodal advanced MR imaging- contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on 3T enables quantitative assessment of treatment response. Quantifying changes in advanced MR imaging techniques would allow predict outcome for early and long-term treatment response and survival in glioblastomas.
- Conditions
- Adult Glioblastoma
- Being tested
- 3 Tesla magnetic resonance imaging, Chemical exchange saturation transfer MRI, Diffusion weighted MRI, Dynamic susceptibility contrast MRI
- Keywords
- Glioblastoma, MRI, standard treatment
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Tesla magnetic resonance imagingDevice
High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)
Chemical exchange saturation transfer MRIDevice
Amide proton transfer-weighted image
Diffusion weighted MRIDevice
diffusion-weighted image with b value 0, 1000, and 3000
Dynamic susceptibility contrast MRIDevice
dual echo EPI sequence
| Study group | Role | What they receive |
|---|---|---|
| MR imaging and standard treatment | Other | Patients with glioblastoma undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and perfusion (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant temozolomide therapy. Receives: Device: 3 Tesla magnetic resonance imaging; Device: Chemical exchange saturation transfer MRI; Device: Diffusion weighted MRI; Device: Dynamic susceptibility contrast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of Response Rate
The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use. Clinical and radiologic assessments were carried out at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant TMZ therapy. Complete Response (CR) was defined as complete disappearance on MR of all enhancing tumor; Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR by bi-dimensional measurement; Pseudoprogression was defined when there was a decrease or stabilization of the contrast-enhancing lesions for a minimum of six months and combined with no change in treatment/ or a increase in contrast-enhancing lesion on the first subsequent follow-up MR image, as long as it stabilized on the second follow-up and there was no need for treatment change. Responder = CR+PR+Pseudoprogression, Non-responder = Progression.
Measured: 6 month
Secondary outcomes (5)
Progression Free Survival (PFS)
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring. Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as >=20% increase in sum of longest diameters (LD) of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Measured: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
Quantitative changes to tumor protein content and tumor acidosis
Amide proton transfer asymmetry (APTasym, %) from Chemical Exchange Saturation Transfer (CEST) Amine proton transfer asymmetry (AmPTasym %) from CEST
Measured: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor cellularity
Apparent diffusion coefficient (ADC, mm2/s) from Diffusion weighted MRI
Measured: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI
Normalized Cerebral blood volume (CBV, %) from dynamic susceptibility contrast (DSC)-MRI
Measured: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI
Initial area-under-the-curve (IAUC) from dynamic contrast enhancement (DCE)-MRI
Measured: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start12 Jan 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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 Adult GlioblastomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Sung Kim, Asan Medical Center
- Investigators
- Ho Sung Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613988
- Sponsor's protocol ID
- AsanMCHSKim_01
- Status last verified
- May 2024
- First submitted
- 18 Nov 2015
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Galban CJ, Chenevert TL, Meyer CR, Tsien C, Lawrence TS, Hamstra DA, Junck L, Sundgren PC, Johnson TD, Galban S, Sebolt-Leopold JS, Rehemtulla A, Ross BD. Prospective analysis of parametric response map-derived MRI biomarkers: identification of early and distinct glioma response patterns not predicted by standard radiographic assessment. Clin Cancer Res. 2011 Jul 15;17(14):4751-60. doi: 10.1158/1078-0432.CCR-10-2098. Epub 2011 Apr 28.
PubMed 21527563Park JE, Kim HS, Goh MJ, Kim SJ, Kim JH. Pseudoprogression in Patients with Glioblastoma: Assessment by Using Volume-weighted Voxel-based Multiparametric Clustering of MR Imaging Data in an Independent Test Set. Radiology. 2015 Jun;275(3):792-802. doi: 10.1148/radiol.14141414. Epub 2015 Jan 21.
PubMed 25611736Park JE, Kim HS, Park KJ, Kim SJ, Kim JH, Smith SA. Pre- and Posttreatment Glioma: Comparison of Amide Proton Transfer Imaging with MR Spectroscopy for Biomarkers of Tumor Proliferation. Radiology. 2016 Feb;278(2):514-23. doi: 10.1148/radiol.2015142979. Epub 2015 Aug 19.
PubMed 26491847Moon HH, Park JE, Kim N, Kim YH, Song SW, Hong CK, Kim JH, Kim HS. Prospective longitudinal analysis of imaging-based spatiotemporal tumor habitats in glioblastoma, IDH-wild type: implication in patient outcome using multiparametric physiologic MRI. BMC Cancer. 2024 Sep 27;24(1):1197. doi: 10.1186/s12885-024-12939-7.
PubMed 39334005
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas
- ClinicalTrials.gov ID
- NCT02613988
- Acronym / sponsor ID
- AsanMCHSKim_01
- Conditions
- Adult Glioblastoma
- Keywords
- Glioblastoma, MRI, standard treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Nov 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.
This clinical trial studies advanced MR imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas.
Detailed description
The standard care of patients with glioblastoma is concomitant chemoradiation and adjuvant temozolomide. Allowing for assessment of tumor therapy prior to treatment completion is important to select patients most likely to benefit from alternative treatment option. Multimodal advanced MR imaging- contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on 3T enables quantitative assessment of treatment response. Quantifying changes in advanced MR imaging techniques would allow predict outcome for early and long-term treatment response and survival in glioblastomas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR imaging and standard treatment | Other | Device: 3 Tesla magnetic resonance imaging, Device: Chemical exchange saturation transfer MRI, Device: Diffusion weighted MRI, Device: Dynamic susceptibility contrast MRIPatients with glioblastoma undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and perfusion (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant temozolomide therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma
- Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter
- Life expectancy of greater than 3 months
- Patients scheduled for standard therapy (6 weeks radiation treatment (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week RT, and followed routine monthly temozolomide therapy)
- Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Key exclusion criteria (6 listed)
- Patients who underwent complete resection
- Patients with no evidence of measurable disease after surgery
- Patients who have had chemotherapy or radiotherapy
- Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
- Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
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 |
|---|---|---|
| 3 Tesla magnetic resonance imagingHigh resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery) | Device | MR imaging and standard treatment |
| Chemical exchange saturation transfer MRIAmide proton transfer-weighted image | Device | MR imaging and standard treatment |
| Diffusion weighted MRIdiffusion-weighted image with b value 0, 1000, and 3000 | Device | MR imaging and standard treatment |
| Dynamic susceptibility contrast MRIdual echo EPI sequence | Device | MR imaging and standard treatment |
Primary outcome
Diagnostic Performance of Response Rate
Time frame: 6 month
The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use. Clinical and radiologic assessments were carried out at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant TMZ therapy. Complete Response (CR) was defined as complete disappearance on MR of all enhancing tumor; Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR by bi-dimensional measurement; Pseudoprogression was defined when there was a decrease or stabilization of the contrast-enhancing lesions for a minimum of six months and combined with no change in treatment/ or a increase in contrast-enhancing lesion on the first subsequent follow-up MR image, as long as it stabilized on the second follow-up and there was no need for treatment change. Responder = CR+PR+Pseudoprogression, Non-responder = Progression.
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)
Quantitative changes to tumor protein content and tumor acidosis
Time frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor cellularity
Time frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor perfusion using dynamic susceptibility contrast MRI
Time frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Quantitative changes to tumor perfusion using dynamic contrast enhancement MRI
Time frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 21527563Galban CJ, Chenevert TL, Meyer CR, Tsien C, Lawrence TS, Hamstra DA, Junck L, Sundgren PC, Johnson TD, Galban S, Sebolt-Leopold JS, Rehemtulla A, Ross BD. Prospective analysis of parametric response map-derived MRI biomarkers: identification of early and distinct glioma response patterns not predicted by standard radiographic assessment. Clin Cancer Res. 2011 Jul 15;17(14):4751-60. doi: 10.1158/1078-0432.CCR-10-2098. Epub 2011 Apr 28.
- Background: PubMed 25611736Park JE, Kim HS, Goh MJ, Kim SJ, Kim JH. Pseudoprogression in Patients with Glioblastoma: Assessment by Using Volume-weighted Voxel-based Multiparametric Clustering of MR Imaging Data in an Independent Test Set. Radiology. 2015 Jun;275(3):792-802. doi: 10.1148/radiol.14141414. Epub 2015 Jan 21.
- Background: PubMed 26491847Park JE, Kim HS, Park KJ, Kim SJ, Kim JH, Smith SA. Pre- and Posttreatment Glioma: Comparison of Amide Proton Transfer Imaging with MR Spectroscopy for Biomarkers of Tumor Proliferation. Radiology. 2016 Feb;278(2):514-23. doi: 10.1148/radiol.2015142979. Epub 2015 Aug 19.
- Derived from this study: PubMed 39334005Moon HH, Park JE, Kim N, Kim YH, Song SW, Hong CK, Kim JH, Kim HS. Prospective longitudinal analysis of imaging-based spatiotemporal tumor habitats in glioblastoma, IDH-wild type: implication in patient outcome using multiparametric physiologic MRI. BMC Cancer. 2024 Sep 27;24(1):1197. doi: 10.1186/s12885-024-12939-7.
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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.
Ho Sung Kim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 Tesla magnetic resonance imaging, Chemical exchange saturation transfer MRI and Diffusion weighted MRI in people with Adult Glioblastoma, run by Asan Medical Center at 1 site in South Korea.
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 5 inclusion and 6 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 14 May 2024. 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 South Korea. 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 Ho Sung Kim, MD, PhD (+82230105682, radhskim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of Response Rate (time frame: 6 month). 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 NCT02613988, 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 14 May 2024.