NCT03297125

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

8.1 years

First QC Date

September 26, 2017

Last Update Submit

October 13, 2025

Conditions

Glioblastoma

Keywords

Optune TherapyMRINovoCure-TTF-200A

Outcome Measures

Primary Outcomes (2)

  • Overall survival.

    The number of subjects alive at six months.

    Six months.

  • Overall survival.

    The number of subjects alive at one year.

    One year.

Study Arms (1)

Eligible Subjects

All enrolled subjects undergoing Optune therapy.

Device: Standard Magnetic Resonance Imaging (MRI)Device: Advanced MRI.

Interventions

Standard Magnetic Resonance Imaging (MRI)DEVICE

Standard MRI.

Eligible Subjects
Advanced MRI.DEVICE

Perfusion and diffusion MRI.

Eligible Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with newly diagnosed or recurrent glioblastoma who have self-selected Optune therapy (group 1) or declined Optune therapy (group 2).

You may qualify if:

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

You may not qualify if:

  • 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 (e.g., deep brain stimulator (DBS), spinal cord stimulator, pacemaker, defibrillator, vagus nerve stimulator, programmable shunt).
  • Karnofsky Performance Status (KPS) \< 60.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53202, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Jennifer Connelly, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

December 1, 2017

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)