Clinical trial NCT05139277: Evaluation of the CONVIVO System
Official title: Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal From Abnormal Tissue During Brain Tumor Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
Glial Tumor
Brain Metastases
Meningioma
Schwannoma
Pituitary Tumor
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Carl Zeiss Meditec, Inc.
First posted: 2021-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Adult patients (age\>18) presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates and provide informed consent.
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. The study team hypothesize that there will be a high degree of correlation between images obtained with the CONVIVO system and conventional histologic interpretation.

Detailed description: The surgical resection of brain tumors is an integral component of modern neuro-oncology. . Extent of resection has been found to be associated with increased overall and progression free survival, with the greatest benefit occurring in the setting of a complete or gross total resection. Unfortunately, there are a number of obstacles unique to brain tumors that may limit the extent of resection. A number of advancements in neurosurgical oncology have emerged to improve the extent of tumor resection while decreasing operative morbidity and mortality. Confocal reflectance microscopy is a routine technique used to visualize tissues without fixation or staining used in classical histological techniques. Laser scanning confocal microscopy (LSCM) is an optical fluorescence imaging modality used for imaging thick in vivo and ex vivo tissues. Clinically available confocal endomicroscopy systems contain lasers with precise excitation wavelengths and dichroic filters for detecting appropriate emission wave lengths. The studies completed to date do not evaluate the ability of confocal microscopy to discriminate between normal and abnormal tissue at the margins during surgical resection. This is the first of such in vivo feasibility studies that aims to demonstrate this claim of the CONVIVO system.

The images acquired with the CONVIVO system following administration of fluorescein will be compared to conventional histologic specimens from corresponding biopsies. This is a planned single center study. This study is designed to assess the diagnostic accuracy of the CONVIVO system compared with gold-standard histopathology in tissue that has already been identified for resection. The device will not be used to inform surgical decision making, nor will tissue that would not otherwise be resected be biopsied for research purposes.

This study will rely on study investigators, all physicians at Dartmouth-Hitchcock, to identify subjects. Written consent is required for participation in the study.. There are no specific medical risks to patients associated with the use of CONVIVO. It is not anticipated that there are immediate or direct benefits to patients participating in this study. The CONVIVO imaging data acquired during the procedure will be initially stored on the device's hard drive and later securely uploaded to an encrypted Dartmouth-Hitchcock server. Patients will have the ability to maintain their privacy with minimal disruption or contact by the study team. Additionally, the PI or other investigators will have interactions with the patient as part of their routine clinical care. Participants are free to withdraw from participation in the study at any time upon request.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age\>18)
* Adults presenting with suspected intracranial gliomas (including glioblastoma), cerebral metastasis, meningiomas, acoustic neuromas, and pituitary adenomas, who are surgical candidates
* Adults able to provide informed consent.

Exclusion Criteria:

* Pregnancy
* Children (age \<18 years)
* Fluorescein sodium (FNa) allergy

Primary outcomes:
measure: Diagnostic performance of CONVIVO in discriminating between normal and abnormal tissue
timeFrame: On day of Surgery, Day 0
Secondary outcomes:
measure: Degree of concordance with histologic diagnosis
timeFrame: On day of surgery, Day 0
measure: Sensitivity and Specificity of CONVIVO system
timeFrame: On day of surgery, Day 0
measure: Rate of uninterpretable or non-diagnostic imaging with the CONVIVO system.
timeFrame: On day of surgery, Day 0
measure: Correlation between intra-operative confocal microscopy and co-registered MRI points.
timeFrame: On day of surgery, Day 0
measure: Correlation between visible yellow-light fluorescence (560 nm filter) and intraoperative confocal microscopy.
timeFrame: On day of surgery, Day 0
measure: Correlation between visible blue-light fluorescence and quantitative fluorescence measurements
timeFrame: On day of surgery, Day 0
measure: Extent of tumor resection
timeFrame: 2 Days after surgery up to one month.
measure: Adverse events related to the administration of fluorescein
timeFrame: Day of surgery (Day 0), 2 Days after surgery up to one month.
measure: Time to interpretation of imaging and histology
timeFrame: Day of surgery (Day 0), and up to one week
measure: Ability to discriminate between viable tumor and pseudoprogression or "treatment effect" using the CONVIVO system.
timeFrame: Day of surgery (Day 0) and up to one month
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Linton T Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: