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cCeLL Imaging for Brain Cancer

N/A

Waitlist Available

Led By Sunit Das, MD, PhD, MA, BA

Research Sponsored by VPIX Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients, ≥ 19 years of age

Patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 6 months post-operation

Awards & highlights

Study Summary

This trial will compare cCeLL imaging accuracy to standard biopsy practices for brain tumor removal surgery. Participants will consent to having both procedures done on their tumor tissue.

Who is the study for?

This trial is for men and women over 19 years old who are suspected to have a brain tumor and are scheduled for neurosurgery. They must be able to understand and give informed consent. It's not open to patients who've had multiple surgeries on the same lesion.Check my eligibility

What is being tested?

The trial tests if cCeLL imaging can match or exceed the accuracy of standard biopsy methods during brain tumor surgery, and if it can do so more quickly. Participants will have their removed tumor tissue examined by both cCeLL and traditional biopsies.See study design

What are the potential side effects?

Since this study involves comparing two diagnostic techniques post-tumor removal, there are no direct side effects from the intervention itself; however, typical risks associated with surgical procedures still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 19 years old or older.

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I am scheduled for brain surgery to possibly remove a tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 6 months post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 6 months post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 6 months post-operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

cCeLL Ex Vivo and Frozen Section Agreement

Secondary outcome measures

Comparison of imaging and analysis duration of cCeLL Ex vivo compared to frozen section

Number of images required to diagnose cCeLL imaging

The total number of non-diagnostic cCeLL Ex-vivo images.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients already scheduled for brain tumor surgeryExperimental Treatment1 Intervention

The biological specimens (hereafter referred to as 'tissue') and/or images to be used in this trial must be collected from patients who are male or female and ≥ 19 years of age, and the patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection. There will be up to three (3) tissue sample types assessed for each participant: 1- center-of-tumor, 2- normal tissue (collected from inevitable standard resection), and 3- margin tissue. Tissues will be removed as part of the standard neurosurgical procedure. Resected tissue will be cleaned, stained, and imaged ex-vivo using cCeLL. Image recordings of sample tissue using cCeLL - Ex vivo are taken and the obtained data is stored.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VPIX MedicalLead Sponsor

Samsung Medical CenterOTHER

1,025 Previous Clinical Trials

5,308,885 Total Patients Enrolled

Unity Health TorontoOTHER

541 Previous Clinical Trials

447,680 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there open slots remaining for this research trial?

"The clinicaltrials.gov website reports that this medical research trial, which was first posted in early January of 2024 and last updated on October 18th 2023 is not presently enrolling participants. However, there are numerous other trials currently seeking potential patients to join their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

2024. "cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06098248.

All > Brain Tumor