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Procedure

CONVIVO System for Brain Tumor Detection

N/A

Recruiting

Led By Linton T Evans, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

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

Must have

Adult patients (age>18)

Be older than 18 years old

Must not have

Children (age <18 years)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of surgery (day 0), 2 days after surgery up to one month.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare an imaging system to traditional biopsies to test if it can accurately detect brain tumor tissue during surgery.

Who is the study for?

This trial is for adults over 18 with suspected brain tumors like gliomas, meningiomas, and pituitary adenomas who can undergo surgery. It's not for pregnant individuals, children under 18, or those allergic to Fluorescein sodium.

What is being tested?

The CONVIVO system is being tested against standard tissue evaluation during brain tumor surgery. The goal is to see if the CONVIVO's in-situ images match up well with traditional biopsy results.

What are the potential side effects?

Since the CONVIVO system involves imaging during surgery rather than a drug or invasive procedure, side effects are minimal but may include discomfort from the imaging process.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old.

Exclusion Criteria

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

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days after surgery up to one month.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days after surgery up to one month.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days after surgery up to one month. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissue

Secondary study objectives

Ability to discriminate between viable tumor and pseudoprogression or "treatment effect" using the CONVIVO system.

Adverse events related to the administration of fluorescein

Correlation between intra-operative confocal microscopy and co-registered MRI points.

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Conventional histologic evaluationExperimental Treatment1 Intervention

Following image acquisition, the tissue region imaged with the CONVIVO system will then be biopsied using biopsy forceps. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample.

Group II: CONVIVO systemExperimental Treatment1 Intervention

During tumor resection, study investigators trained in the use of the system will determine when the CONVIVO imaging system will be used for in vivo¬ imaging. At this point 5 mg/kg of fluorescein will be administered intravenously by an anesthesia provider over one minute.Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique.

0 / 2Eligibility criteria met