GammaTile

Evidence with impact

Clinical studies show GammaTile consistently delivers outcomes that matter for patients with operable brain tumors.

A growing body of
peer-reviewed studies shows
consistent results:

Strong local tumor control and low rates of radiation necrosis for patients with operable brain tumors. Explore the evidence that’s shaping the future of brain tumor radiation therapy.1-8

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GammaTile® clinical evidence:
Proven local control (LC) and
low rates of radiation necrosis (RN)

Safety and efficacy data review:

Newly Dx & Recurrent Brain Mets (BM)
StudyBeckham 2025Zeller 2024
PMID: 39429969
Study
Design		RetrospectiveProspective
(Registry)
# Patients 3128
# Treated
Tumors		3830
Tumor
Type		BM (Recurrent)Brain Mets
(Newly Dx)
Efficacy
Outcome		87% LC at 12 mos.
94% LC at 12 mos.
with GTR		NR
(Perioperative
safety analysis)
Safety8% Symptomatic RN
2.6% Infection
12.9% LMD		Serious AE: 3.6%
Total AE: 21.4%
No AE was
definitively related
to GammaTile
Newly Dx & Recurrent Brain Mets (BM)
StudyDharnipragada 2023
PMID: 37,324,216		Kutuk 2023
PMID: 37,722,990
Study
Design		RetrospectiveRetrospective
# Patients 1010
# Treated
Tumors		1012
Tumor
Type		Rapidly Growing
Brain Mets
(Newly Dx & Recurrent)		Brain Mets
(Recurrent)
Efficacy
Outcome		100% LC at median follow up of 6.2 mos.100% LC at 6, 12, and 18 mos.
SafetyNo RN
No Surgical Complications		8% Symptomatic RN
Newly Dx & Recurrent Brain Mets (BM)
StudyImber 2022
PMID: 35,896,906		Nakaji 2020
PMID: 33,224,684
Study
Design		ProspectiveProspective
# Patients 2011
# Treated
Tumors		2516
Tumor
Type		Brain Mets
(Recurrent)		Brain Mets
(Newly Dx & Recurrent)
Efficacy
Outcome		92% LC at 12 months83% LC at 12 mos.
Newly Dx (n=4): 100% LC at 12 mos.
Recurrent (n=12): 80% LC at 12 mos.
Safety16% Symptomatic RN12.5% Radiation Brain Changes
Newly Dx (n=4) = 0%
Recurrent (n=12) = 12.5%
Newly Dx & Recurrent Glioblastoma
StudyYekula 2024
PMID: 38281303		Smith 2022
PMID: 36,322,102
Study
Design		ProspectiveProspective
# Patients 728
# Treated
Tumors		728
Tumor
Type		Rapidly Growing GBM
(Newly Dx & Recurrent)		Glioblastoma
(Recurrent)
Efficacy
Outcome		Median OS
Newly Dx (n=3): 11.5 mos.
Recurrent (n=4): 10 mos.
Median PFS (All): 10.6 mos.		Median time to LF: 12.1 mos.
Median OS: 25.0 mos.
Median PFS: 11.7 mos.
SafetyNo RN
No Surgical Complications		7% Symptomatic RN
Newly Dx & Recurrent Glioblastoma
StudyGessler 2022
PMID: 35,088,050
Study
Design		Prospective
# Patients 22
# Treated
Tumors		22
Tumor
Type		IDH Wild-type
Glioblastoma
(Recurrent)
Efficacy
Outcome		86% LC at 6 mos.
81% LC at 12 mos.
Median OS:
24.4 mos.
Median PFS:
8.2 mos.
SafetyNo RN
9% Pts with Surgical Complications
Recurrent Meningioma
StudyBrachman 2018
PMID: 30,579,269
Study
Design		Prospective
# Patients 19
# Treated
Tumors		20
Tumor
Type		Meningioma
(Recurrent)
Efficacy
Outcome		Median OS:
26 mos.
89% PFS at 18 mos.
Safety10% RN
10% Pts with Surgical Complications
StudyStudy
Design		# Patients# Treated
Tumors		Tumor TypeEfficacy OutcomeSafety
Newly Dx & Recurrent Brain Mets (BM)
Beckham 2025Retrospective3138BM (Recurrent)87% LC at 12 mos.
94% LC at 12 mos. with GTR 		8% Symptomatic RN
2.6% Infection
12.9% LMD
Zeller 2024
PMID: 39429969		Prospective
(Registry)		2830Brain Mets
(Newly Dx)		NR
(Perioperative safety analysis)		Serious AE: 3.6%
Total AE: 21.4%
No AE was definitively related to GammaTile
Dharnipragada 2023
PMID: 37,324,216		Retrospective1010Rapidly Growing
Brain Mets
(Newly Dx & Recurrent)		100% LC at median
follow up of 6.2 mos.		No RN
No Surgical Complications
Kutuk 2023
PMID: 37,722,990		Retrospective1012Brain Mets
(Recurrent)		100% LC at 6, 12, and
18 mos.		8% Symptomatic RN
Imber 2022
PMID: 35,896,906		Prospective2025Brain Mets
(Recurrent)		92% LC at 12 months16% Symptomatic RN
Nakaji 2020
PMID: 33,224,684		Prospective1116Brain Mets
(Newly Dx & Recurrent)		83% LC at 12 mos.
Newly Dx (n=4):
100% LC at 12 mos.
Recurrent (n=12):
80% LC at 12 mos.		12.5% Radiation
Brain Changes
Newly Dx (n=4) = 0%
Recurrent (n=12) = 12.5%
Newly Dx & Recurrent Glioblastoma
Yekula 2024
PMID: 38281303		Prospective77Rapidly Growing GBM
(Newly Dx & Recurrent)		Median OS
Newly Dx (n=3): 11.5 mos.
Recurrent (n=4): 10 mos.
Median PFS (All): 10.6 mos.		No RN
No Surgical Complications
Smith 2022
PMID: 36,322,102		Prospective2828Glioblastoma
(Recurrent)		Median time to LF: 12.1 mos.
Median OS: 25.0 mos.
Median PFS: 11.7 mos.		7% Symptomatic RN
Gessler 2022
PMID: 35,088,050		Prospective2222IDH Wild-type
Glioblastoma
(Recurrent)		86% LC at 6 mos.
81% LC at 12 mos.
Median OS: 24.4 mos.
Median PFS: 8.2 mos.		No RN
9% Pts with Surgical Complications
Recurrent Meningioma
Brachman 2018
PMID: 30,579,269		Prospective1920Meningioma
(Recurrent)		Median OS: 26 mos.
89% PFS at 18 mos.		10% RN
10% Pts with Surgical Complications

LC = Local Control, LF = Local Failure, LMD = Leptomeningial Disease, NR = Not Reported, PFS = Progression-Free Survival, RN = Radiation Necrosis
Adapted from Garcia MA, et al. J Neurooncol. 166:203-212 (2024).

Proven local control:Proven
local control:
100% LC with 12 previously irradiated
brain mets | clinical and dosimetric evidence

Clinical evidence: 100% LC at 6, 12 and 18 months |
n = 12 tumors1

Kutuk T, et al. Brachytherapy 2023.

Dosimetric evidence: retrospective dosimetric
review of radiation treatment options:
recurrent brain mets | n = 12 tumors9

Kutuk T, et al. Brachytherapy 2024.

Axial illustration demonstrating the differences in biologically effective dose (BED) distribution amongst the radiation modalities

Images courtesy of Miami Cancer Institute.

BED10Gy90% Median

Key Insights

  • GammaTile delivers statistically significant higher biologically effective dose (BED) at the resection cavity (RC) than other modalities (CyberKnife®, p = 0.04, Gamma Knife®, p = 0.005, Proton Therapy, p = 0.003).
  • GammaTile’s BED was significantly lower 5mm away from the RC as compared to CyberKnife® (p = 0.045) and proton therapy (p = 0.03).
  • Dose metrics associated with RN are significantly lower for GammaTile on pairwise comparisons (all p <0.05).

The GammaTile Commitment Pledge
for recurrent brain tumors

If a GammaTile treatment of a recurrent brain tumor is canceled because intraoperative pathology reveals only necrotic tissue, we will update the invoice to reflect a $0 charge.*

CONTACT USORDER NOW
For more information on GammaTile clinical evidence,
please contact us.
* Per the GammaTile Commitment Product Policy, effective December 31, 2023. A purchase order must be submitted for the original order and the customer must not have any past due invoices with GT Medical Technologies. Additional Terms and Conditions apply. Please contact Customer Service for complete policy details.

REFERENCES: 1. Kutuk T, et al. Brachytherapy. 22(6):872-881 (2023). 2. Dharnipragada R, et al. Neurooncol Adv. 5(1):vdad062 (2023). 3. Imber BS, et al. J Neurooncol. 159(3):609-618 (2022). 4. Nakaji P, et al. Cureus. 12(11):e11570 (2020). 5. Yekula A, et al. J Neurooncol. 166(3):441-450 (2024). 6. Gessler DJ, et al. Neurooncol Adv. 4(1):1-11 (2022). 7. Smith N, et al. Neuro Oncol. 24(S6):S4-S15 (2022). 8. Brachman DG, et al. J Neurosurg. 131(6):1819-1828 (2018). 9. Kutuk T, et al. Brachytherapy. 23(6):751-760 (2024).

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