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Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI

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ClinicalTrials.gov Identifier: NCT03297125
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Connelly, MD, Medical College of Wisconsin

Brief Summary:
The purpose of this prospective, nonrandomized controlled phase IV study is to compare standard and advanced MRI for their ability to predict response to Optune therapy.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Glioblastoma Glioblastoma Device: NovoCure-TTF-200A Phase 4

Detailed Description:

Protocol Summary: Optune therapy is a newly approved treatment for patients with glioblastoma. This therapy demonstrated comparable outcomes for patients with recurrent GBM, in comparison to standard therapies, but better quality of life. More recently, in an interim analysis of 315 patients with GBM, adding TTFields to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival. It also has demonstrated promise in other cancers such as pancreas, mesothelioma, ovarian and lung. However, in order to optimize the treatment regimen, and potentially predict which patients are most likely to respond, reliable ways of evaluation are necessary. Advanced perfusion and diffusion MRI methods have shown utility with other treatments such as bevacizumab. Preliminary data suggests the same might be true for the evaluation of Optune therapy. The team therefore proposes to determine the utility of these methods to predict response to Optune therapy. A successful result will have wide-ranging implications not only for the optimization of Optune treatment of brain cancer but also other cancers shown to benefit from this novel therapy.

Objective: To compare standard and advanced MRI for their ability to predict response to Optune therapy. The team's approach will be to obtain both standard and advanced MRI in patients with newly diagnosed glioblastoma undergoing adjuvant chemotherapy plus Optune therapy. The ability of standard and advanced MRI to predict response will be assessed. The hypothesis is that perfusion and/or diffusion imaging metrics can be used to predict response to and elucidate mechanisms of action for Optune treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Device: NovoCure-TTF-200A

How TTFields works:

Adhesive bandages hold insulated ceramic discs (transducer arrays) that deliver electricity transformed into electromagnetic energy to the scalp. The battery operated-TTF device generates low intensity, intermediate frequency, alternating electrical fields to the brain. These electrical fields exert selective toxicity in proliferating cells thereby halting cell division and destroying the cancer cells.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Imaging: Standard MRI
Anticipated Results/Interpretation Standard anatomic imaging will prove not to be reliable for evaluation of progression free survival, but may show some ability to predict overall survival.
Device: NovoCure-TTF-200A
Adhesive bandages hold insulated ceramic discs (transducer arrays) that deliver electricity transformed into electromagnetic energy to the scalp. The battery operated-TTF device generates low intensity, intermediate frequency, alternating electrical fields to the brain. These electrical fields exert selective toxicity in proliferating cells thereby halting cell division and destroying the cancer cells.

Experimental: Imaging: Advanced MRI
Anticipated Results/Interpretation Advanced MRI methods will demonstrate the ability to predict response earlier than with standard MRI methods.
Device: NovoCure-TTF-200A
Adhesive bandages hold insulated ceramic discs (transducer arrays) that deliver electricity transformed into electromagnetic energy to the scalp. The battery operated-TTF device generates low intensity, intermediate frequency, alternating electrical fields to the brain. These electrical fields exert selective toxicity in proliferating cells thereby halting cell division and destroying the cancer cells.




Primary Outcome Measures :
  1. In comparing the difference in the proportion of survival predicted by the two methods (standard versus advanced MRI), a McNemar test will be used. [ Time Frame: Two years ]
    For 30 subjects enrolled in this study (over two years), assuming the proportion of discordant pairs is 0.30; the team will achieve 80% power to detect a difference between two paired proportions of 0.27 with a significance level of 0.05. Further, the team can give estimates of the positive predictive values of each method along with the 95% CI. If the difference between the two methods is smaller than what is assumed here, then the team will not be able to get a significant result with the provided sample size.


Secondary Outcome Measures :
  1. Using diffusion-weighted imaging (DWI), collect images at several different diffusion weightings and evaluate them by applying several different post-processing techniques. [ Time Frame: Two years ]
    This information will provide specific micro-structural and cellular information about tumors.



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:

  • Newly diagnosed glioblastoma (GBM), WHO grade IV.

Exclusion Criteria:

  • Optune compliance < 75%; they would be excluded from the final analyses.
  • History of craniectomy or significant skull defect (contraindication to Optune).
  • Active implantable medical device (i.e. DBS, spinal cord stimulator, pacemaker, defibrillator, vagus nerve stimulator, programmable shunt).
  • Karnofsky Performance Status (KPS) < 60.

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): NCT03297125


Contacts
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Contact: Medical College of Wisconsin Clinical Cancer Center 414-805-8900 cccto@mcw.edu

Locations
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United States, Wisconsin
Froedtert Hospital & Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53202
Contact: Jennifer Connelly, MD    414-805-5200    JConnelly@mcw.edu   
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office    414-805-8900    cccto@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Jennifer Connelly, MD Medical College of Wisconsin

Publications:
Rivera, F., et al. PANOVA: A pilot study of TTFields concomitant with gemcitabine for front-line therapy of advanced pancreatic adenocarcinoma. in 2015 ASCO Annual Meeting. 2015. Chicago, IL.
Farber, O. A phase II trial of TTFields with chemotherapy for first line treatment of malignant mesothelioma. in International Association for the Study of Lung Cancer. 2015. Santa Monica, CA.
Cohen, A.D., et al. IVIM and DSC metrics are heightened in rat C6 brain tumors. in 20th Annual Meeting of the International Society of Magnetic Resonance in Medicine (ISMRM). 2012. Melbourne, Australia.
2005-2006 Primary brain tumors in the United States statistical report: 1998-2002 data collected., C.B.T.R.o.t.U. States, Editor. 2005
Cohen, A.D., et al. The effect of b-value on ADC values in a rat U87 brain tumor model. in 22nd Annual Meeting of the International Society of Magnetic Resonance in Medicine (ISMRM). 2014.Milan, Italy.

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Responsible Party: Jennifer Connelly, MD, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03297125    
Other Study ID Numbers: PRO00000087
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jennifer Connelly, MD, Medical College of Wisconsin:
Optune Therapy
MRI
NovoCure-TTF-200A
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