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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique called qOBM to help surgeons see and remove brain tumors more clearly during surgery. It focuses on individuals with specific brain tumors, such as glioblastoma, astrocytoma, or oligodendroglioma, who require surgery. The goal is to ensure the complete and safe removal of the tumor. Individuals with a newly discovered brain tumor or a known tumor that is growing and require a craniotomy (a type of brain surgery) might be suitable candidates. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could improve surgical outcomes for future patients.

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 prior data suggests that this imaging technique is safe for detecting brain tumors?

Previous studies have shown that quantitative oblique back-illumination microscopy (qOBM) can safely assist doctors in identifying brain tumors and their edges during surgery. Research indicates that qOBM is non-invasive, meaning it does not harm the body while capturing images. This technique allows doctors to clearly view the tumor and surrounding areas without using dyes or other substances. As this trial is in an early stage, safety data remains limited. However, because qOBM is a non-invasive imaging tool, it is expected to be well-tolerated. Available studies have not reported any harmful side effects from this technique. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard imaging techniques for brain cancer, Quantitative Oblique Back-Illumination Microscopy (qOBM) offers a unique way to assess tumors during surgery. Researchers are excited about qOBM because it provides real-time, detailed images of the brain tissue, potentially improving the precision of tumor removal. This method could enhance the accuracy of surgeries by allowing surgeons to see the tumor more clearly and make better-informed decisions on the spot. Ultimately, qOBM may lead to better outcomes for patients by reducing the likelihood of leaving cancerous tissue behind.

What evidence suggests that this imaging technique is effective for detecting brain tumor margins?

Research has shown that quantitative oblique back-illumination microscopy (qOBM), which participants in this trial will undergo, could greatly assist in brain tumor surgeries. Studies have found that qOBM uses scattered light to create clear images of thick brain tissues, revealing tumor details and edges more clearly. In animal tests, qOBM successfully identified the edges of brain tumors without special dyes. This suggests that qOBM could make brain surgeries more precise by clearly showing where tumors end. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeffrey J. Olson, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9243522/

Functional imaging with dynamic quantitative oblique back- ... We propose dynamic qOBM to achieve functional imaging based on subcellular dynamics, potentially indicative of metabolic activity.

2. biorxiv.org biorxiv.org/content/10.1101/2025.07.29.667497v1.full.pdf

Single Capture Quantitative Oblique Back-Illumination ... We assess the performance of these DL-based phase retrieval algorithms by conducting experiments involving the reconstruction of two biomedical ...

3. spiedigitallibrary.org spiedigitallibrary.org/conference-proceedings-of-spie/13329/1332906/Three-dimensional-quantitative-phase-imaging-for-the-evaluation-of-glioblastoma/10.1117/12.3039313.full

Three-dimensional quantitative phase imaging for the ... In this study, we introduce quantitative Oblique Back-illumination Microscopy (qOBM) as a novel imaging technique for longitudinal, non-invasive ...

4. opg.optica.org opg.optica.org/abstract.cfm?uri=BRAIN-2023-BTh2B.3

Toward Real-time In-Vivo Diagnosis of Brain Tumors using ... Quantitative oblique back-illumination microscopy (qOBM) utilizes multiply scattered light inside thick tissues to realize epi-mode quantitative phase imaging.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7984798/

Towards in-vivo label-free detection of brain tumor margins ... Data from a bulk and infiltrative brain tumor animal model show that qOBM enables quantitative phase imaging of thick fresh brain tissues with ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2022-06212

An Investigational Imaging Technique (Quantitative ... qOBM may assist doctors in detecting brain tumor and its margins with surrounding normal tissue more safely and reliably in patients with glioblastoma, ...

7. clinconnect.io clinconnect.io/trials/NCT05513859

Investigational Imaging Technique During Brain Surgery This early phase I trial tests the safety and reliability of an investigational imaging technique called quantitative oblique back illumination microscopy ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40766649/

Single Capture Quantitative Oblique Back-Illumination ... We demonstrate that SCqOBM achieves remarkable phase imaging accuracy, closely matching the results of traditional four-capture qOBM in diverse ...

9. researchgate.net researchgate.net/publication/391552233_Longitudinal_and_continuous_label-free_monitoring_of_glioblastoma_patient-derived_tumor_spheroid_treatment_response_using_quantitative_oblique_back_illumination_microscopy

(PDF) Longitudinal and continuous label-free monitoring of ... In this study, we introduce quantitative Oblique Back-illumination Microscopy (qOBM) as a novel, label-free, and non-invasive imaging approach ...

10. opg.optica.org opg.optica.org/abstract.cfm?uri=oe-30-11-17713

Optimization of a flexible fiber-optic probe for epi-mode ... Quantitative oblique back-illumination microscopy (qOBM) is an emerging label-free optical imaging technology that enables 3D, ...