Investigational Imaging Technique for Brain Cancer

Overseen By Francisco E. Robles, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Needle biopsy, Infection, Heart failure, others

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

Compensation: Varies

Number of Visits: 2

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This early phase I trial tests the safety and reliability of an investigational imaging technique called quantitative oblique back illumination microscopy (qOBM) during brain surgery for detecting brain tumors and brain tumor margins in patients with glioblastoma, astrocytoma, or oligodendroglioma. Surgical margins refer to the edge or border of the tissue removed in cancer surgery. qOBM may be able to assess and reveal brain tumor surgical margins in a more safe and reliable manner.

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 coordinators or your doctor.

What data supports the effectiveness of this treatment for brain cancer?

Research shows that Cesium-131 brachytherapy, a type of radiation treatment, is effective and safe for brain tumors, offering advantages over other isotopes by minimizing complications and improving outcomes. It has been used successfully in patients with resected brain tumors, showing promising results in terms of safety and radiation protection. ^{1 2 3 4 5}

Is the investigational imaging technique for brain cancer safe for humans?

Cesium-131 brachytherapy, used in brain tumor treatments, has been shown to be safe with limited radiation exposure to patients, family, and medical staff. Studies indicate that it maintains safe levels of radiation, minimizing complications and ensuring safety for those involved. ^{2 3 4 5 6}

How is the treatment Craniotomy with Cs-131 Brachytherapy unique for brain cancer?

This treatment uses Cesium-131, a radioactive isotope, to deliver targeted radiation directly to brain tumors, minimizing radiation exposure to surrounding healthy tissue and potentially reducing side effects compared to other isotopes like iodine-125. ^{2 3 4 7 8}

Research Team

Jeffrey J. Olson, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

This trial is for adults (18+) who need brain surgery within the next 14 days for a new or worsening glioblastoma, astrocytoma, or oligodendroglioma. Participants must understand the study's nature and agree to its procedures. Those only needing a needle biopsy or with serious health issues like uncontrolled infection, heart problems, or mental illness that could limit compliance are excluded.

Inclusion Criteria

My surgery is scheduled within the next 14 days.

I need surgery to remove a brain tumor.

I have signed a consent form understanding my cancer, the study, and its risks and benefits.

Exclusion Criteria

I am only having a needle biopsy.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Patients undergo craniotomy with intraoperative ex vivo and in situ tumor assessment using qOBM

1 day

1 visit (in-person)

Postoperative Imaging

Patients undergo postoperative exam with CT or MRI any of days 1-5 after surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• Craniotomy
• Quantitative Oblique Back-Illumination Microscopy

Trial Overview The trial tests a new imaging technique called quantitative oblique back-illumination microscopy (qOBM) during brain surgery. It aims to safely and reliably identify tumor edges in patients undergoing craniotomy—a surgical procedure to remove part of the skull to access the brain.

Participant Groups

Group I: Diagnostic (qOBM) Experimental Treatment 2 Interventions

Patients undergo craniotomy with intraoperative ex vivo and in situ tumor assessment with qOBM. Patients then undergo postoperative exam with CT or MRI any of days 1-5 after surgery.

Craniotomy is already approved in United States for the following indications:

Approved in United States as Cs-131 Brachytherapy for:

• Recurrent brain metastases

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Cesium-131 brachytherapy has been shown to be a safe and effective treatment for primary and metastatic brain tumors, with a median follow-up of 16.2 months and a high local progression-free rate of 94%.

The treatment resulted in low rates of complications, such as radiation necrosis (3.4%) and seizures (4.7%), indicating that it minimizes radiation-induced side effects while effectively targeting brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of cesium-131 brachytherapy in brain tumors: a scoping review of the literature and ongoing clinical trials. Palmisciano, P., Haider, AS., Balasubramanian, K., et al.[2022]

In a study of 119 patients treated with Cesium-131 (Cs-131) brachytherapy for CNS tumors, the treatment showed high local control rates, particularly 84.7% for brain metastases and 83.3% for meningiomas, indicating its efficacy across different tumor types.

The safety profile was also favorable, with only 8.4% of patients experiencing radiation necrosis and 11.8% having wound complications, suggesting that Cs-131 brachytherapy is a viable option for managing CNS tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Cesium-131 brachytherapy for brain tumors. Bander, ED., Kelly, A., Ma, X., et al.[2023]

In a study involving 18 patients with recurrent brain metastases, cesium-131 (Cs-131) brachytherapy was used effectively, with a median of 16 seeds implanted per patient, demonstrating its potential as a safe adjunct treatment for brain tumors.

Radiation safety measures were established based on real-time dose rate measurements, ensuring minimal exposure for caregivers and the public, with specific precautions recommended for close contact during the first 1-3 weeks post-implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-specific radiological protection precautions following Cs collagen embedded Cs-131 implantation in the brain. Prasad, K., Dauer, LT., Chu, BP., et al.[2022]

Cesium-131 (Cs) brachytherapy is a safe treatment for patients with resected brain tumors, showing minimal radiation exposure to medical personnel and family members, with most dosimetry badges recording near-zero dose equivalents.

The study found a significant correlation between the number of Cs seeds implanted and the radiation dose rate at the surface, indicating that higher seed counts lead to increased radiation exposure, but still within safe limits according to National Council on Radiation Protection guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Exposure and Safety Precautions Following 131Cs Brachytherapy in Patients with Brain Tumors. Yondorf, MZ., Schwartz, TH., Boockvar, JA., et al.[2022]

GammaTile intracranial brachytherapy, using cesium-131 seeds, was successfully performed during an awake craniotomy in a 50-year-old patient with a glioblastoma, demonstrating the safety and feasibility of this approach.

The procedure allowed for precise tumor resection and custom implantation of the GammaTiles, ensuring effective treatment while preserving critical brain functions, such as speech, due to real-time language mapping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of GammaTile intracranial brachytherapy implanted during awake craniotomy. McClelland, S., Gardner, UG., Le, Y., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tumor resection cavity administered iodine-131-labeled antitenascin 81C6 radioimmunotherapy in patients with malignant glioma: neuropathology aspects. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

The role of cesium-131 brachytherapy in brain tumors: a scoping review of the literature and ongoing clinical trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of Cesium-131 brachytherapy for brain tumors. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Patient-specific radiological protection precautions following Cs collagen embedded Cs-131 implantation in the brain. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Radiation Exposure and Safety Precautions Following 131Cs Brachytherapy in Patients with Brain Tumors. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of GammaTile intracranial brachytherapy implanted during awake craniotomy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Quantitative imaging of iodine-131 distributions in brain tumors with pinhole SPECT: a phantom study. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

Bioluminescence imaging of invasive intracranial xenografts: implications for translational research and targeted therapeutics of brain tumors. [2021]