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Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

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ClinicalTrials.gov Identifier: NCT02613988
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ho Sung Kim, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Adult Glioblastoma Radiation: Radiation Device: 3 Tesla magnetic resonance imaging Device: Chemical exchange saturation transfer MRI Device: Diffusion weighted MRI Device: Dynamic contrast enhancement MRI Device: Dynamic susceptibility contrast MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas
Study Start Date : December 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MR imaging and standard treatment
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.
Radiation: Radiation
Device: 3 Tesla magnetic resonance imaging
Device: Chemical exchange saturation transfer MRI
Device: Diffusion weighted MRI
Device: Dynamic contrast enhancement MRI
Device: Dynamic susceptibility contrast MRI



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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 ]
    Amide proton transfer asymmetry (APTasym, %) from Chemical Exchange Saturation Transfer (CEST) Amine proton transfer asymmetry (AmPTasym %) from CEST

  3. Quantitative changes to tumor cellularity [ Time Frame: Baseline imaging within 4 weeks after surgery and 4 weeks after completion of CCRT ]
    Apparent diffusion coefficient (ADC, mm2/s) from Diffusion weighted MRI

  4. 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 ]
    Normalized Cerebral blood volume (CBV, %) from dynamic susceptibility contrast (DSC)-MRI

  5. 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 ]
    Initial area-under-the-curve (IAUC) from dynamic contrast enhancement (DCE)-MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613988


Contacts
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Contact: Ho Sung Kim, MD, PhD +82230105682 radhskim@gmail.com
Contact: Ji Eun Park, MD +82230101505 jieunp@gmail.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Ho Sung Kim, MD, PhD Asan Medical Center

Publications:
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Responsible Party: Ho Sung Kim, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02613988     History of Changes
Other Study ID Numbers: AsanMCHSKim_01
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Keywords provided by Ho Sung Kim, Asan Medical Center:
Glioblastoma
MRI
standard treatment
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue