Study on GammaTile and Stupp Protocol for Newly Diagnosed Glioblastoma (GBM)

Sponsor: GT Medical Technologies, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05342883

Provider View

This clinical trial is exploring a new approach to treating newly diagnosed glioblastoma (GBM) by adding a special type of radiation therapy called GammaTile to the standard treatment. The study aims to see if this combination can improve patient outcomes by better controlling the tumor and extending survival.

Patient Parameters

Program Overview

This study is testing a new treatment method for patients with newly diagnosed glioblastoma (GBM), a type of brain cancer. The standard treatment usually involves surgery followed by chemotherapy and radiation. However, this approach often doesn't provide long-lasting control of the cancer. The study is introducing GammaTile, a new type of radiation therapy, during surgery to see if it can improve outcomes. GammaTile uses a special material that delivers radiation directly to the tumor site, potentially offering better control of the cancer. The study will evaluate if this method is safe and if it can be combined with the standard treatment without delaying it. The ultimate goal is to see if this approach can be tested in larger studies in the future.

Description

This study is investigating whether adding GammaTile, a new type of radiation therapy, to the standard treatment for newly diagnosed glioblastoma (GBM) can improve patient outcomes. GammaTile is used during surgery to deliver radiation directly to the tumor site, which may help control the cancer more effectively. Patients will receive two types of radiation: GammaTile during surgery and standard radiation therapy afterward. The study will ensure that the combined radiation doses are safe and effective. The first few patients at each study site will have their treatment plans reviewed by a committee to ensure safety. The study aims to show that using GammaTile during surgery is safe and does not delay the start of the standard treatment. It will also look at how well the treatment controls the cancer and extends survival.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of newly diagnosed glioblastoma (GBM) through specific tests.
  • Must have enough tissue available for additional testing.
  • Must have a tumor that can be surgically removed and is no larger than 6 cm.
  • Must be able to receive a specific type of guidance during surgery to help remove the tumor.
  • Must be eligible to receive the standard treatment for GBM, which includes chemotherapy and possibly other therapies.
  • Must not be taking other cancer treatments before the cancer progresses.
  • Must have a performance status score indicating they are in relatively good health.
  • Must be able to understand and sign a consent form.
  • Must be willing to follow the study schedule and procedures.
  • Must use effective birth control during the study and for a period after treatment.
  • Must have satisfactory blood test results before surgery.

Exclusion Criteria

  • Known to have a specific type of glioma that is not eligible for the study.
  • Not suitable for the standard chemotherapy treatment.
  • Have had previous cancer treatments that overlap with the study area.
  • Have tumors that cannot be fully removed in one surgery.
  • Have tumors that extend into certain areas of the brain that make surgery difficult.
  • Have had another invasive cancer within the last two years, except for certain skin or cervical cancers.
  • Have cancer outside the brain that requires treatment.
  • Are taking or planning to take other cancer treatments not allowed in the study.
  • Are enrolled in another study or taking investigational therapies.
  • Have allergies to study medications or materials.
  • Have severe health conditions that would interfere with the study.
  • Are pregnant or breastfeeding.
  • Are taking other therapies that could interfere with the study.
  • Have a psychiatric condition that affects their ability to participate in the study.
  • Are unable to understand the study or follow its requirements.

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