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GammaTile for Glioblastoma
(BRIDGES Trial)

Overseen ByKimberly Johnson

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GT Medical Technologies, Inc.

Must be taking: TMZ

Disqualifiers: Previous biopsy, Contraindications, Multi-focal tumors

Stay on Your Current MedsYou can continue your current medications while participating

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment option for glioblastoma, a type of brain cancer. Researchers aim to determine if adding GammaTile therapy, a form of radiation treatment, to the current standard treatment of surgery and chemotherapy is more effective. Participants will be divided into two groups: one will receive the standard treatment, while the other will receive the standard treatment plus GammaTile. The study seeks individuals newly diagnosed with glioblastoma who are ready for surgery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GammaTile, a treatment for brain tumors, is generally safe. In previous studies, most patients tolerated the treatment well. Only 21% of patients experienced complications, with just 3.6% being serious. Serious side effects, such as changes in brain tissue from radiation, were uncommon.

Another study found no issues with wound healing, indicating that GammaTile is safe for patients. This treatment is well-tolerated and has shown promise in controlling tumors locally. The current trial is in a late stage, indicating that GammaTile has already been tested for safety in earlier trials. This provides some confidence in its safety for new participants.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

GammaTile is unique because it integrates a novel delivery method directly into the surgical site, targeting glioblastoma cells more precisely. Unlike standard treatments like external beam radiation therapy (EBRT) and temozolomide (TMZ) alone, GammaTile delivers localized radiation immediately after tumor resection, potentially reducing the chance of cancer recurrence. Researchers are excited about GammaTile because it combines surgery with targeted radiation, aiming to minimize damage to healthy brain tissue while maximizing the treatment's effectiveness against remaining cancer cells.

What evidence suggests that GammaTile might be an effective treatment for glioblastoma?

Research has shown that GammaTile, a treatment under study in this trial, delivers a stronger dose directly to the area where a tumor was removed. This allows it to target cancer cells more precisely than some other treatments. In earlier studies, patients with certain genetic traits who received GammaTile lived longer. Specifically, some patients lived for 20 to 37 months, which is promising compared to typical results. These findings suggest that GammaTile could be an effective option for treating glioblastoma, a type of brain cancer. Participants in this trial may receive GammaTile as part of their treatment regimen.¹ ² ⁶ ⁷ ⁸

Are You a Good Fit for This Trial?

This trial is for adults with suspected new glioblastoma who can undergo surgery, have a KPS score of ≥70, and can receive standard treatment. Excluded are those with previous non-IDH wild-type GBM diagnosis, TMZ contraindications, or multiple tumors not treatable in one operation.

Inclusion Criteria

Have radiographic suspicion of newly diagnosed glioblastoma (GBM)

I am fit for surgery to remove my tumor.

I am 18 years old or older.

See 3 more

Exclusion Criteria

A previous biopsy diagnosis other than IDH wild-type GBM

I cannot have TMZ or certain imaging tests due to health reasons.

I have multiple tumors that cannot be removed in a single surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Perioperative/Operative

Patients undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B)

EBRT and Concurrent TMZ

EBRT and TMZ administered up to 5 days a week for 6 weeks in Arm A and 4 weeks in Arm B

4-6 weeks

Adjuvant TMZ

TMZ administered for the first 5 days of each 28-day cycle, up to 12 cycles

6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

External Beam Radiation Therapy
GammaTile
Temozolomide

Trial Overview The study compares two approaches after tumor removal: Arm A receives standard radiation therapy (EBRT) and Temozolomide (TMZ), while Arm B gets GammaTile implants plus shorter EBRT and TMZ. The trial includes several phases from surgery to follow-up.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Active Control

Group I: Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B)Experimental Treatment3 Interventions

All patients will undergo tumor resection + GammaTile implantation. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 20-fraction course of EBRT for 4 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles.

Group II: Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A)Active Control2 Interventions

All patients will undergo tumor resection. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 30-fraction course of EBRT for 6 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles.

Find a Clinic Near You

Who Is Running the Clinical Trial?

GT Medical Technologies, Inc.

Lead Sponsor

Trials

Recruited

1,700+

Citations

1.gammatile.comgammatile.com/hcp/clinical-evidence/

Clinical Evidence: Healthcare ProvidersKey Insights. GammaTile delivers statistically significant higher biologically effective dose (BED) at the resection cavity (RC) than other modalities ( ...

2.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC8788013/

GammaTile® brachytherapy in the treatment of recurrent ...Median overall survival (OS) was 20.0 months for the MGMTu patients and 37.4 months for MGMTm patients. These outcomes compared favorably to data in the ...

3.clinicaltrials.govclinicaltrials.gov/study/NCT05342883

Study Details | NCT05342883 | GammaTile and Stupp in ...The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol.

4.gammatile.comgammatile.com/clinical-trials

GammaTile Clinical TrialsThe purpose of this study is to see if Cs-131 brachytherapy (GammaTile) is effective in people with recurrent brain metastases who are scheduled to have brain ...

5.cancer.govcancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-10369

GammaTile and Stupp in Newly Diagnosed GBM - NCIThe aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol.

6.gammatile.comgammatile.com/

GammaTile Radiation TherapySerious side effects related to GammaTile Therapy are rare, and may include radiation brain changes including necrosis. GammaTile Therapy should not be used for ...

7.academic.oup.comacademic.oup.com/noa/article/6/1/vdae156/7754263

Early experience and perioperative risk of GammaTile for ...Their results showed that 21% of patients had complications from GammaTile; however, only 3.6% were considered serious by the authors.

8.sciencedirect.comsciencedirect.com/science/article/abs/pii/S1538472124003416

PO0318: GammaTile Cs-131 Permanent Brain ImplantsThe preliminary results from this small cohort of patients with recurrent GBM treated with GT showed a trend towards improved local recurrence free survival ...

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GammaTile for Glioblastoma
(BRIDGES Trial)

What You Need to Know Before You Apply

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Citations

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GammaTile for Glioblastoma (BRIDGES Trial)

What You Need to Know Before You Apply

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Citations

Other People Viewed

Related Searches

GammaTile for Glioblastoma
(BRIDGES Trial)