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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgery (day 0), 2 days after surgery up to one month.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am over 18 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissue
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,540,759 Total Patients Enrolled
Carl Zeiss Meditec, Inc.Industry Sponsor
22 Previous Clinical Trials
5,620 Total Patients Enrolled
Linton T Evans, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

CONVIVO System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05139277 — N/A
Meningioma Research Study Groups: CONVIVO system, Conventional histologic evaluation
Meningioma Clinical Trial 2023: CONVIVO System Highlights & Side Effects. Trial Name: NCT05139277 — N/A
CONVIVO System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139277 — N/A

Frequently Asked Questions

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

To what extent is the trial participant pool increasing?

"Affirmative. In accordance with clinicaltrials.gov, this research effort is still recruiting patients since its June 28th 2022 commencement date and most recent August 29th 2023 edit. The project requires 30 participants across a single medical centre to be enrolled in the trial."

Answered by AI

Is recruitment for this research project still open?

"As per data posted on clinicaltrials.gov, this medical experiment is open for recruitment and was initially published in late June of 2022. The information has been recently revised on August 29th 2023."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of the CONVIVO System
Linton T. Evans 2022. "Evaluation of the CONVIVO System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05139277.
All > Pituitary Tumor > Meningioma
~11 spots leftby Jun 2025
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