Study on SonoCloud-9 with Carboplatin vs. Standard Chemotherapies for Recurrent Glioblastoma

Sponsor: CarThera

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05902169

Provider View

This clinical trial is testing a new approach using the SonoCloud-9 device with the chemotherapy drug carboplatin to see if it can improve treatment for patients with recurrent glioblastoma, a type of brain cancer. The study compares this new method to standard chemotherapy treatments.

Patient Parameters

Program Overview

The brain has a protective barrier called the blood-brain barrier (BBB) that prevents many drugs from reaching brain tumors. This study is testing the SonoCloud-9 device, which uses ultrasound to temporarily open the BBB, allowing more of the chemotherapy drug carboplatin to reach the brain tumor. The goal is to see if this combination can be more effective in treating recurrent glioblastoma compared to standard chemotherapy treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with glioblastoma, a type of brain cancer, without a specific IDH mutation.
  • Previously received surgery or biopsy, radiation therapy, and at least one type of chemotherapy or biological therapy.
  • The cancer has clearly progressed, with a measurable tumor size, and enough time has passed since the last radiation treatment.
  • Eligible for surgery to remove at least half of the tumor.
  • Tumor size before joining the study must be 5 cm or smaller.
  • In good general health, able to perform daily activities with minimal assistance.
  • Aged 18 years or older.
  • Recovered from any side effects of previous cancer treatments.
  • Have adequate blood, liver, and kidney function based on recent tests.
  • Able to understand the study and willing to sign a consent form.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for a month after treatment.
  • Men must agree to use condoms during the study and for three months after treatment, and not donate sperm during this time.
  • Must have health insurance that covers routine care costs and be part of a social security scheme.

Exclusion Criteria

  • Have multiple tumors unless they are all within a 5 cm area.
  • Tumor located in the back of the brain.
  • Known mutations in BRAF or NTKR genes.
  • High risk of infection at the surgery site.
  • Taking high doses of steroids recently.
  • Allergic to carboplatin or other study drugs.
  • Allergic to components used in the ultrasound device.
  • Have received certain treatments like bevacizumab for reasons other than treating swelling.
  • Have nerve damage or uncontrolled seizures.
  • Have certain brain conditions like aneurysms or significant bleeding.
  • Have medical devices that cannot be removed.
  • Need to be on blood thinners that cannot be stopped.
  • Taking certain epilepsy medications.
  • Have had another cancer in the last three years, except for some skin cancers or cervical cancer.
  • Have active or chronic infections.
  • Have significant heart or lung conditions.
  • Allergic to contrast agents used in imaging tests.
  • Have issues with temperature regulation.
  • Pregnant or breastfeeding.
  • Any other serious medical or psychological conditions that could interfere with the study.
  • Under legal protection or unable to make decisions independently.

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