Skip to content
DataLookout
Start free
Menu

NCT04135807

Implantable Microdevice In Primary Brain Tumors

StatusRecruiting
PhaseEarly Phase 1
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 12 → 30 participants Show 4 more changesShow less
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised
  2. Primary completion date: Sep 21, 2027 to Jan 21, 2028
    • Study completion date: Jul 1, 2028 to Jun 1, 2028
    v6
  3. Lead sponsor: Oliver Jonas, PhD to Oliver Jonas
    • Primary completion date: Sep 21, 2023 to Sep 21, 2027
    • Study completion date: Feb 1, 2024 to Jul 1, 2028
    v5
  4. Lead sponsor: Oliver Jonas to Oliver Jonas, PhD
    • Primary completion date: Sep 21, 2021 to Sep 21, 2023
    • Study completion date: Feb 1, 2022 to Feb 1, 2024
    v4
  5. Primary completion date: Jan 21, 2021 to Sep 21, 2021
    • Study completion date: Feb 1, 2021 to Feb 1, 2022
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2019 to Mar 3, 2020
    • Site details revised
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Success Rate of Microdevice Retrieval
Timeframe: 3 days
Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0
Timeframe: 3 Days

Secondary (2)

Measure Local Intratumor Response to Different Agents
Correlate Tissue Genetic Features with Drug Response

Arms and interventions

MicrodeviceExperimental

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Patients with newly found supratentorial lesions, or patients previously diagnosed with supratentorial gliomas at time of recurrence, whose treatment plan includes partial or total resection surgery as a component of standard-of-care treatment will be included. Placement of 1-3 microdevices (depending on the size of the tumor) \~3 days before planned tumor resection. The drugs used in this study will include drugs used systemically for the treatment of gliomas, as well as investigational agents being studied for gliomas: TMZ, Lomustine, Irinotecan, Carboplatin, Lapatinib, Niraparib, Osimertinib, Abemaciclib, and Everolimus, Nivolumab, Opdualag, Ipilimumab, Gabapentin, Perampanel, Tocilizumab, Meclofenam, Bumetanide, Prochloperazine, Decitabine, PTC596, RNA-containing lipid nanoparticle (including compounds CL3, SCR, CL3\_a2), Vortioxetine.

Combination products: Microdevice

Sites

1 site in 1 country

  • Brigham and Women's HospitalBoston, Massachusetts, United States