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Combining GammaTile and Stupp protocol for newly diagnosed glioblastoma

Pilot Study of Resection and GammaTile Followed by Concomitant External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant in Newly Diagnosed Glioblastoma (GBM)

Phase 4 Interventional GT Medical Technologies, Inc. · NCT05342883

This study is testing if using a new type of radiation therapy called GammaTile during surgery can help people with newly diagnosed glioblastoma live longer and have better control of their cancer when combined with standard chemotherapy and radiation treatments.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment61 (estimated)
Ages18 Years and up
SexAll
SponsorGT Medical Technologies, Inc. Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy, radiation
Locations16 sites (Scottsdale, Arizona and 15 other locations)
Trial IDNCT05342883 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility and tolerability of using GammaTile radiation therapy as an upfront boost during surgery for patients with newly diagnosed glioblastoma (GBM), alongside the standard Stupp protocol of chemotherapy and external beam radiation therapy (EBRT). The approach aims to enhance local control and overall survival by integrating a novel brachytherapy device that delivers targeted radiation directly to the tumor site. Patients will receive a combination of GammaTile and EBRT, with careful monitoring of radiation doses to ensure safety and effectiveness. The study will also involve oversight by a Clinical Oversight Committee to evaluate treatment planning and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed newly diagnosed GBM and specific molecular characteristics.

Not a fit: Patients with IDH mutated tumors or those who do not meet the molecular criteria for GBM will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved local control and overall survival for patients with newly diagnosed glioblastoma.

How similar studies have performed: While the use of GammaTile is a novel approach in this context, similar strategies in other cancers have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. All patients must be ≥ 18 years of age
2. Histopathological and molecular confirmation of newly diagnosed GBM using IDH mutation testing (such as immunohistochemistry for IDH1 R132H) must be performed as part of SOC. A central lab will perform cytogenetics testing. Note: In patients without prior biopsy, diagnosis will be suspected preoperatively, but must be confirmed by molecular testing (i.e., must be IDH wild type). Patients with confirmed pathology from biopsy prior to enrollment are able to participate if they meet all other study requirements. Enrolled patients not ultimately confirmed to have molecular GBM or are found to have IDH mutated tumors after resection and GT placement (if appropriate), will be followed for safety. If tested before screening, patients known to have IDH mutated tumors should not be invited to participate or consented/enrolled.
3. Adequate tissue for central submission to determine methylation promoter status. Patients with either methylated or unmethylated MGMT promoter status are included, and this status must be confirmed by central pathology review. Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate MGMT promoter status will receive GT (if indicated) and will be part of the ITT/safety population but will be excluded from the PP population analyses.
4. A supratentorial tumor that in the opinion of the enrolling neurosurgeon is a) amenable to attempted gross total resection (GTR) and b) has a maximum preoperative diameter of 6 cm or less when considering all tumor planned for resection (enhancing and non-enhancing). If multifocal, must be fully resectable in one operative bed. Prior diagnostic biopsy allowed. Surgical protocol will follow current institutional standards. If intraoperative MRI is utilized, details will be captured.
5. Able to receive 5-aminolevulinic acid (5-ALA, Gleolan) or other institutionally standard immunofluorescent-guidance such as fluorescein, prior to surgery to optimize GTR of enhancing tumor.
6. Patient is appropriate candidate to receive SOC treatment for newly diagnosed GBM as usually practiced (Stupp protocol with at least 6 cycles and up to 12 cycles of TMZ).
7. Concomitant systemic or local anti-cancer medications or treatments are prohibited in this study (with the exception of TTF) before progression.
8. Anti-angiogenic therapy (e.g., bevacizumab and its biosimilars) or steroid use is allowed for symptom management (e.g., brain edema or symptomatic pseudoprogression) as per institutional standard. Note: For both agents, utilization of the lowest useful doses and shortest useful courses are encouraged. At failure, tumor therapeutic dose of anti-angiogenic therapy (e.g., bevacizumab and its biosimilars) or other therapies can be utilized for treatment at the investigators' discretion.
9. Karnofsky Performance Scale (KPS) score of ≥ 70.
10. Eastern Cooperative Oncology Group Performance Score (ECOG-PS) of 0-2.
11. Ability to understand and the willingness to sign (personally or by a legally authorized representative) the written IRB approved informed consent document prior to performance of any study-related procedures.
12. Ability to understand English or Spanish.
13. Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up after treatment termination.
14. Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
15. Satisfactory hematology as evidenced by standard pre-surgery labs:

    1. Hemoglobin ≥ 10 g/dl
    2. Leukocytes ≥ 2,000/mm3
    3. Absolute neutrophil count (ANC) ≥ 1,500/mm3
    4. Platelets ≥ 100,000/mm3
    5. Total bilirubin ≤ 2.0 x institutional/lab upper limit of normal (ULN)
    6. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) ≤ 2.5 x ULN
    7. Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN
    8. Serum creatinine ≤ 1.5 x ULN OR creatinine clearance (CrCl) ≥ 50mL/min (if using the Cockcroft-Gault formula)
    9. Absolute lymphocyte count between 1,000 and 4,800 per microliter of blood.

Exclusion Criteria:

1. Known to be IDH mutated glioma by prior biopsy.
2. Patients not appropriate for concomitant or maintenance temozolomide.
3. Previous chemotherapy or radiotherapy to the head or neck region resulting in overlapping fields or prior surgery to the brain to resect other brain tumors.
4. Staged surgery planned (prior biopsy allowed).
5. Bilateral tumors, or multi-focal tumors that cannot be encompassed in one operative field.
6. Enhancing extension into brainstem or thalamus, or significant invasion into the corpus callosum that would preclude a high likelihood of GTR.
7. Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ) unless disease free for a minimum of 2 years
8. Definitive clinical or radiologic evidence of cancer outside the brain (excluding nonmelanomatous skin cancer, or other types of indolent cancers) not needing active treatment within the past 2 years. Contact the Medical Monitor to review any inquiries on indolent cancers allowed.
9. Concomitant systemic or local anti-cancer medications or treatments in use or planned (with the exception of TTF before progression or on protocol TMZ).
10. Planned use of adjuvant anti-angiogenic therapy (e.g., bevacizumab and its biosimilars) specifically for tumor treatment
11. Enrollment in another investigational study or planned use of investigational therapies. Note: Experimental therapies or enrollment in a subsequent study are allowed after a patient on study has a local recurrence or distant brain failure.
12. Patients with contraindication to MRI or CT
13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide, bovine -derived collagen, 5-ALA or other institutionally standard immunofluorescent-guidance compounds, such as fluorescein.
14. Participants with severe intercurrent illness that will prohibit subsequent chemotherapy and radiotherapy including, but not limited to, unstable systemic disease including ongoing or active infection, COVID-19, uncontrolled hypertension, serous cardiac arrythmia requiring medication, acute cardiovascular disease or clinically manifested myocardial insufficiency or history of myocardial infarction during the past 6 months prior to screening, severe psychiatric illness or other illness that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and adverse events of the prescribed regimens.
15. Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine test or serum beta human chorionic gonadotrophin (b-HCG) documented no greater than 14 days prior to study registration unless they are surgically sterile (e.g. oophorectomy, hysterectomy, tubal ligation) or menopausal. Menopause is defined as 12 months of amenorrhea in a woman over 45 in the absence of possible causes for amenorrhea (e.g., low body fat, hormonal imbalances, etc.)
16. Any concomitant therapy (e.g., strict ketogenic diet, high dose vitamin C) that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of any of the study treatments.
17. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent.
18. Participants who, in the investigator's opinion, are unable to understand the protocol or to give informed consent (personally or by a legally authorized representative), have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care.

Where this trial is running

Scottsdale, Arizona and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GlioblastomaNewly DiagnosedStuppGammaTileExternal Beam Radiation TherapyTemozolomideResectionBrain
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.