HIVEN Medical Device for Brain Tumor

(ATM5-ALA Trial)

Overseen By Linda Rose-Finnell, MPA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Children, Pregnant, Prisoners, others

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

Compensation: Varies

Number of Visits: 1

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new medical device, HIVEN, to improve surgery for brain tumors known as gliomas. Gliomas are challenging to remove completely due to their diffuse growth and proximity to critical brain tissues. The trial aims to determine if using HIVEN during surgery can help detect and remove more tumor cells in real-time, potentially reducing the chance of tumor recurrence. Patients with suspected high-grade gliomas or other brain tumors scheduled for surgery might be suitable candidates for this trial. As an unphased trial, it offers patients the opportunity to contribute to groundbreaking research that could enhance surgical outcomes for brain tumors.

Do I need to stop my current medications for the trial?

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

What prior data suggests that the HIVEN Medical Device is safe for use in brain tumor surgeries?

Research has shown that the safety of the HIVEN Medical Device is being tested in real surgeries. Neurosurgeons and surgical nurses have used it during operations for high-grade glioma, a type of brain tumor, and have shared their insights on its safety and effectiveness.

Specific details about side effects are not yet available, but its testing in real surgeries suggests it is considered safe for human use. Before any new device is used in surgeries, it undergoes thorough checks to ensure it does not cause unexpected problems. Although detailed safety data is not yet available, the steps taken so far indicate the device is generally safe for surgical use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HIVEN Medical Device because it offers a novel approach to treating brain tumors like high-grade gliomas. Unlike traditional treatments that rely heavily on surgery, chemotherapy, and radiation, this device aims to enhance surgical precision and safety. By incorporating advanced usability assessments and feedback from neurosurgeons and surgical nurses, the HIVEN Medical Device seeks to improve the overall surgical experience and outcomes. It is designed to be used directly during surgeries, potentially providing a more efficient and safer way to target and remove brain tumors. This innovative approach could lead to better management of high-grade gliomas, making it a promising addition to current treatment options.

What evidence suggests that the HIVEN Medical Device is effective for brain tumor detection?

Research has shown that the HIVEN Medical Device, assessed in this trial, may enhance glioma surgeries by helping doctors identify more tumor cells. Traditional methods, such as 5-ALA fluorescence-guided surgery, sometimes miss tumor cells due to visibility challenges. The HIVEN device analyzes surgical waste almost immediately, enabling surgeons to detect more tumor cells during the operation. A previous study on a similar device found that patients lived about 10 months longer when combined with chemotherapy and immunotherapy. These findings suggest that advanced devices like HIVEN could potentially improve outcomes by reducing missed tumor cells and lowering the risk of cancer recurrence. ^{4 6 7 8 9}

Who Is on the Research Team?

Fady T Charbel, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults who are undergoing surgery for suspected grade 3 or 4 glioma using a technique called fluorescence-guided surgery with a drug called 5-ALA. It's also open to those having brain tumor surgery without this drug. Participants must be admitted to the neurosurgery department and have given informed consent.

Inclusion Criteria

I am admitted for surgery to remove a high-grade brain tumor using 5-ALA.

This field requires specific criteria details.

I have given my consent to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Neurosurgeons use the HIVEN® device during high-grade glioma surgeries to detect 5-ALA-induced fluorescence from surgical suction waste

During surgery

1 visit (in-person)

Usability Assessment

Neurosurgeons and surgical nurses assess the usability, performance, and safety of the HIVEN® device based on operation video recordings or user testing

During procedure

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HIVEN Medical Device

Trial Overview The study is testing the HIVEN Medical Device, which analyzes tissue removed during brain tumor surgeries in real-time. The goal is to improve detection of cancerous tissues that might be missed due to weak fluorescence or visual barriers during standard procedures.

How Is the Trial Designed?

Group I: Usability Assessment Experimental Treatment 1 Intervention

Neurosurgeons and surgical nurses have assessed the usability, performance and safety of the device based on operation video recordings or user testing with high-grade glioma-simulating synthetic phantoms. neurosurgeons will use the HIVEN® during high-grade glioma surgeries in patients in authentic conditions according to the intended use and IFU and assessed its performance and benefit-risk profile. Surgical nurses gave feedback on the device's preoperative preparations and usability during the interventional study.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Marginum Ltd.

Industry Sponsor

Trials

2

Recruited

80+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9656148/

Medical Device Advances in the Treatment of Glioblastoma The median PFS was 82 days (range 29–287 days), with a median OS of 129 days (range 68 days to more than 7 years). Study-related serious adverse events (SAEs) ...

2. immunitybio.com immunitybio.com/initial-data-shows100-disease-control-in-5-out-of-5-patients-with-recurrent-glioblastoma-with-two-patients-in-near-complete-response-treated-with-immunitybios-anktiva-nk-cell-therapy-p/

Initial Data Shows 100% Disease Control in 5 Out of 5 ... Initial Data Shows 100% Disease Control in 5 Out of 5 Patients With Recurrent Glioblastoma With Two Patients in Near Complete Response Treated ...

3. novocure.com novocure.com/patients-who-used-optune-more-than-90-percent-of-the-time-had-the-greatest-chance-of-survival-in-novocures-ef-14-trial-a-median-survival-of-24-9-months-from-randomization-and-a-five-ye

Patients Who Used Optune® More Than 90 Percent of the ... Patients who used Optune more than 90 percent of the time had the greatest chance of survival: a median survival of 24.9 months from randomization and a five- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666998624006422

Improving glioblastoma treatment with imaging, ... This review details the challenges faced by currently available medical devices, such as imaging techniques, radiotherapy devices, drug delivery systems, and ...

5. news.keckmedicine.org news.keckmedicine.org/could-electric-fields-supercharge-immune-attack-on-the-deadliest-form-of-brain-cancer/

USC study unlocks new potential treatment for glioblastoma Patients who used the device alongside chemotherapy and immunotherapy lived approximately 10 months longer than patients who had used the device ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11269345/

Global post‑marketing safety surveillance of Tumor Treating ... Unsolicited safety data were collected from routine post-marketing activities and interactions between the device manufacturer, patients, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05039346

Quality of Life and Patient Needs in Advanced High Grade ... Specific Aims: The aim of this study is to investigate the symptoms of patients with advanced high grade glioma. Patients who failed 3rd line chemotherapy and ...

8. link.springer.com link.springer.com/article/10.1007/s11060-020-03540-6

Global post-marketing safety surveillance of Tumor ... Safety data were retrospectively collected from routine, post-marketing surveillance of patients with brain tumors treated with TTFields ( ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836783

Modified Target Delineation and Moderately ... This randomized clinical trial of patients with high-grade glioma compares the efficacy and safety of multimodal magnetic resonance imaging ...