← Back to Search

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

Must not have

Patient has undergone several surgeries on lesion of interest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up perioperative

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am 19 years old or older.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had multiple surgeries on the lesion in question.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ perioperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~perioperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and perioperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

cCeLL - Ex vivo and Frozen Section Agreement

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met