Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Varun Monga, MD
Study ID
NCT05410301
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Static Magnetic and Electric (sBE) device — DEVICE
    Home-based Static Magnetic and Electric (sBE) device that is slept in
  • Lomustine — DRUG
    Chemotherapy drug
  • Bevacizumab — DRUG
    Chemotherapy and targeted therapy drug

Study Details

A prospective, open label, single-center, early feasibility trial will be conducted to assess the safety and feasibility of a home-based Static Magnetic and Electric (sBE) device applied for 8 hours/day during sleep in adult participants with recurrent glioblastoma (rGBM) at their first relapse.

Key Dates

First listed
Jun 8, 2022
Start date
Apr 30, 2023
Status verified
Apr 2023
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients: sBE device applied during sleep, in combination with Lomustine and Bevacizumab
    The sBE device is to be used 8 hours a day by the patients, during sleep, for 8 weeks, while also receiving standard chemotherapy Lomustine and Bevacizumab
  • Experimental: Partners of Patients (who sleep in same bed): sBE
    Up to 12 associated unaffected partners may agree to sleep within the investigational sBE device congruent with the period of exposure of their rGBM partner (8 weeks + possible extension)

Primary Outcome Measure

Greater than or equal to 80% sBE compliance as determined by device pressor sensors, participant reporting via daily diary, and participant completion of sBE Device Questionnaire [ Time Frame: From initiation of therapy through 8 weeks of therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals & ClinicsIowa CityIowa52242-

Find similar trials in Iowa City, IA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Iowa Hospitals & Clinics· Iowa City, IA

Related Studies