Brain Tumor Clinical Trial
— Neuro-qFHSIOfficial title:
Intraoperative Hyperspectral Imaging for Real-time Fluorescence-guided Surgery of Low Grade Glioma
NCT number | NCT05397574 |
Other study ID # | 307291 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | June 30, 2025 |
Verified date | November 2023 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to obtain images of brain tumours during surgery using a new type of surgical camera. The study will assess how the information obtained from the images during surgery matches the removed tissue. Data will also be used to develop the system's key computer-processing features. This will enable real-time information to be given to the surgeon whilst they are performing the procedure and has the potential to make neurosurgery safer and more precise.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients aged 18 years and over - Patients with a diagnosis of a probable glioma (any grade), who are scheduled for elective surgery - Patients able to provide written informed consent Exclusion Criteria: - Patients under 18 years of age - Patients who have previously had brain surgery - Patients unable to provide written informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of qFHSI data with histological analysis of the corresponding biopsied pathological tissue | To correlate ex vivo and in vivo qFHSI data with histological analysis of the corresponding biopsied glioma tissue | 6-12 months | |
Secondary | Safety of qFHSI in surgery | To demonstrate safety of our intraoperative qFHSI device during glioma surgery | 24-36 months | |
Secondary | Tissue diagnosis | To collect ex vivo and in vivo qFHSI data during glioma surgery for tissue analysis, algorithmic development and testing | 24 months | |
Secondary | Accuracy of biophotonics algorithm | To evaluate accuracy of the computational biophotonics algorithm to determine 5-ALA-PpIX concentration in imaged tissue | 24-36 months | |
Secondary | Qualitative assessment | A qualitative assessment of the impact that using the device has on surgical workflow | 24-36 months |
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