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Trial record 44 of 93849 for:    5

Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04055688
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : September 5, 2019
Olympus Corporation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:

5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.

This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.

Condition or disease Intervention/treatment
Brain Tumor Glioma Device: Orbeye surgical videomicroscope Drug: 5-Aminolevulinic Acid

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Participants with known or suspected high grade gliomas Device: Orbeye surgical videomicroscope
The ORBEYE surgical microscope is an FDA-cleared apparatus designed to facilitate operating procedures that involve fine nerves, blood vessels, and other small anatomic features by providing an enlarged stereoscopic visual field of the surgical site. The 4K 3D digital images of the ORBEYE microscope provide high-resolution stereoscopic images of the fine structures of tissue and blood vessels. As the surgical procedures are displayed on a large 55-inch monitor, the device is expected to reduce fatigue of the operator by eliminating the need for extensive viewing via microscope eyepieces for an extended period of time. The technology adopted in the ORBEYE was developed by Sony Olympus Medical Solutions, and its product design was handled by Olympus Medical Systems Corp. The ORBEYE is marketed by the Olympus Corporation.

Drug: 5-Aminolevulinic Acid
5- aminolevulinic acid (5-ALA) is a European Medicines Agency- and Food and Drug Administration- (FDA-) approved drug that is administered to patients 2 to 4 hours before surgery and converted preferentially by tumor cells to protoporphyrrin IX (PPIX). PPIX fluoresces red when exposed to blue light. Use of 5-ALA has previously been shown to permit surgeons to obtain a more complete tumor resection, and its use has also been associated with an increased rate of progression-free survival.(3) There are currently 2 surgical microscope systems available on the market that are equipped with a 5-ALA visualization system. These visualization systems are currently classified by the FDA as Class I-exempt accessories to Class I-cleared surgical microscopes.
Other Name: 5-ALA

Primary Outcome Measures :
  1. Compare Visualized Fluroescence within brain tumors [ Time Frame: Surgery day one ]
    6 tissue samples will be obtained intraoperatively for each patient and assessed for 5-ALA visualization (strongly positive.weakly positive/negative). Tissue samples will be submitted for pathological assessment to determine whether tumor cells are present or absent. Visualization results will be evaluated against the pathology results (gold standard) to determine the sensitivity, specificity, positive predictive value and negative predictive value for 5-ALA visualizations with use of the ORBEYE system.

Secondary Outcome Measures :
  1. Volume of Residual tumor [ Time Frame: up to 48 hours after surgery ]
    Residual tumor volume will be identified in post surgical MRI scans. Extent of resection will be compared to preoperative MRI scans.

  2. Number of Patients experiencing Adverse Events [ Time Frame: Up to 16 days after surgery ]
    Patients will be assessed for neurological and general side effects/toxicities 7-16 days after surgery.

Other Outcome Measures:
  1. Post Surgery Questionnaire [ Time Frame: Surgery day one ]
    Surgeons will complete a questionnaire after each surgery to assess the visual experience of using the ORBEYE during the surgical procedure. The questionnaire asks about the superiority of the ORBEYE system compared to conventional binocular microscope, using a scale of 1-5, 1 being strongly agree and 5 being strongly disagree.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Glioma patients at Moffitt Cancer Center

Inclusion Criteria:

  • Must have a suspected or biopsy-proven high-grade glioma (World Health Organization grade II or IV), new or recurrent.
  • Indication for craniotomy for removal of a suspected or recurrent brain tumor
  • Karnofsky Performance Scale >/- 60%

Exclusion Criteria:

  • Prophyria, hypersensitivity to porphyrins
  • Renal insufficiency as defined per protocol
  • Hepatic insufficiency as defined per protocol
  • Existing pregnancy (to be checked by a pregnancy test if of child-bearing age.
  • Nursing women or women using inadequate contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04055688

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United States, Florida
H. Lee Moffitt Cancer and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Yazmin Rodriguez    813-745-3353   
Principal Investigator: Michael A Vogelbaum, MD, PhD         
Sub-Investigator: James Liu, MD         
Sub-Investigator: Arnold Etame, MD, PhD         
Sub-Investigator: Nam Tran, MD, PhD         
Sub-Investigator: Richard Macaulay, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Olympus Corporation
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Principal Investigator: Michael A Vogelbaum, MD, PhD H. Lee Moffitt Cancer and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT04055688     History of Changes
Other Study ID Numbers: MCC-20014
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Orbeye Surgical Microscope
fluorescence-guided surgery
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents