CONVIVO Endomicroscopy

Study Purpose

Visualization of the tissue microstructure during neurosurgery using a non destructive handheld imaging technology producing a real time digital image ("optical biopsy") at cellular resolution is a novel method that holds great promise for optimization and improvement of the surgical treatment of brain pathologies, brain tumors in particular. The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

The patient is suffering from an intracranial lesion requiring surgery:

- Patients undergoing neurosurgical resection for intrinsic presumably high grade, invasive tumors.

- Patients undergoing neurosurgical resection for other brain tumors,.

- All patient groups will only be comprised of elective surgical patients who have signed the informed consent prior to use.

Exclusion Criteria:

- History of hypersensitivity to fluorescein.

- History of allergy or bronchial asthma.

- Renal failure - Children (patients less than 18 years of age) - Pregnant women.

- Breast feeding women.

- Patients with inability to give informed consent

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06087393
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Northwell Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor

Additional Details

During surgery for the removal of brain tumors, frozen-section biopsies are routinely taken intraoperatively to help the surgeon to distinguish abnormal tissue areas from normal tissue, and to assess and guide the extent of tumor or mass resection. Frozen-section analysis is time-consuming and freezing may produce architectural artifacts in the tissue sample that are difficult to interpret. As well, some tumors are heterogeneous in cell composition, so a tissue biopsy in one area may not represent the entire tumor mass. Biopsies acquired at the border regions or margins of the surgical resection are especially crucial, because it is at those regions where decisions based on tissue analysis guide the surgeon to further extend the resection where there is more tumor tissue remaining, or halt the resection for various reasons. In practice, the number of biopsies that can be taken during surgery is limited, because the acquisition procedure is time consuming. A technology which enables intraoperative real-time visualization of tissue at cellular resolution could provide a significant advantage in defining abnormal tissue margins. Such a technology could be used to identify abnormal tissue or at a minimum could screen for the most relevant areas from which formal biopsies should be acquired. It also could help to make the process of taking biopsies more efficient, so that the total number of biopsies needed can be reduced, thus increasing positive biopsy yield. This effort is a follow-up to a previous confocal endomicroscopy in vivo study conducted at the Barrow Neurological Institute in Phoenix. Based on this work, the upgraded version of the confocal laser endomicroscopy (CONVIVO) received 510k clearance from FDA. This study aims to evaluate the learning curve associated with the intraoperative imaging of tissue microstructure and microvasculature during neurosurgical procedures using fluorescein as a contrast agent for 30 patients undergoing surgery for a working diagnosis of brain tumor. The procedure involves a small microscope (about the size of a neurosurgical suction device) which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The focus of this study will be to examine the quality of images taken from the tumor core and tumor margin, and assess the time required for both neurosurgeon and pathologist to agree on a good image. A good image is clear, has well-defined structures, very few artifacts, and is comparable to a standard frozen section biopsy in its diagnostic potential.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Northwell Health, Manhasset, New York

Status

Recruiting

Address

Northwell Health

Manhasset, New York, 11030

Site Contact

Betsy Moclair

[email protected]

516-253-7753