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Loupe-Based Intraoperative Fluorescence Imaging

Study Purpose

Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections. This study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
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.

Observational
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - adults with brain malignant gliomas undergoing resection.
  • - at least 18 years of age.
  • - able to understand the consent.

Exclusion Criteria:

  • - pregnant women.
  • - under 18 years of age.
  • - patients undergoing emergency surgery.
- inability to give consent due to dysphagia or language barrier

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.

NCT04780009
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.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Guoqiang Yu
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Guoqiang Yu, PhD
Principal Investigator Affiliation University of Kentucky
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme, Anaplastic Astrocytoma
Additional Details

This is a prospective, observational study to compare the measurement accuracies of a wearable loupe-based device and the large microscope against the gold standards of postoperative histopathological analysis on tumor tissues. At the induction of anesthesia, patients will receive 5 mg/kg of intravenous sodium 5-aminolevulinic acid (5-ALA) or fluorescein. Surgery will be performed under the guidance of the operative fluorescence microscope (PENTERO with fluorescence kit + YELLOW 560, Carl Zeiss) or (PENTERO 900 + BLUE 400, Carl Zeiss). The operating room light will be dimmed for optimum reproduction of the fluorescent light. Tumor removal will be continued until no fluorescent area is visualized. To evaluate the accuracy of the device in the identification of tumor tissue, six samples will be biopsied from the tumor resection margin for each patient; three in the fluorescent area and three in the non-fluorescent area for the assessment of positive and negative predictive values of the devices, respectively. These biopsied tissues will be taken to the clinical pathology laboratory for the standard histological analysis. To compare the accuracy of the two imaging systems in identifying tumor tissues, the tumor resection area will be visually observed by the surgeon and video recorded using the new loupe-based device at two time points (at least): immediately before and immediately after tumor removal. Additional fluorescence images may be taken during surgery as long as the surgical workflow is not impacted. Moreover, the four fresh biopsies (2 in the fluorescent area and 2 in the non-fluorescent area) taken from the tumor margin based on the operative microscope diagnosis will also be examined intraoperatively by the loupe-based device to determine whether they are fluorescent or non-fluorescent. To discriminate between clear tumor tissue and the peritumoral areas, the postoperative histological analysis of the biopsied samples taken from the tumor margins will be classified on the basis of the current 2016 WHO classification. The neuropathologist will be blinded to the fluorescence characteristics of the biopsied samples.

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.

University of Kentucky, Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky

Lexington, Kentucky, 40536

Site Contact

Thomas Pittman, MD

[email protected]

859-323-8986