Studies
| Study First Submitted Date | 2021-12-11 |
| Study First Posted Date | 2021-12-28 |
| Last Update Posted Date | 2023-03-09 |
| Start Month Year | April 30, 2019 |
| Primary Completion Month Year | December 31, 2022 |
| Verification Month Year | March 2023 |
| Verification Date | 2023-03-31 |
| Last Update Posted Date | 2023-03-09 |
Detailed Descriptions
| Sequence: | 20753009 |
| Description | Background: Diffuse reflectance spectroscopy is an optically based technique which measures the amount of diffusely reflected light after it has undergone multiple scattering and absorption events within the tissue. Each DRS spectrum therefore has a specific 'optical fingerprint' reflecting the composition and morphology of the tissue within the probing volume. The technology is easily built into very small instruments that can be fused with regularly used surgical equipment. DRS has previously been widely investigated for the purpose of margin assessment in other regions of the body. Aim & Hypothesis: The primary goal is to show the feasibility of applying optical tissue sensing using diffuse reflectance spectroscopy (DRS) to differentiate healthy cerebral tissue from tumorous tissue in ex vivo human tissue samples. This will be a basis for further development of surgical equipment able to identify the margin between healthy brain tissue and tumor tissue intraoperatively. Method: Using DRS we aim to determine spectroscopy thresholds that enables differentiation of cerebral tissue from different forms of tumor tissue. We aim to determine these thresholds by collecting DRS data on ex vivo brain and tumor samples. The tumor samples will be part of the normal extraction of tissue during tumor surgeries and the non tumorous tissue can be extracted in temporal/frontal lobe resections as well as epilepsy surgery, where non tumorous brain tissue is to be removed. The DRS measurements are performed in direct connection to the extraction of tissue during surgery, and the tissue is thereafter sent to the pathologist according to standard clinical procedures. No extra tissue will need to be resected for the purpose of this study. Based on the experiments we will propose a theoretical model for differentiating normal cerebral tissue from tumor tissue in humans for use during surgery. |
Facilities
| Sequence: | 200369894 |
| Name | Karolinska University Hospital |
| City | Stockholm |
| Zip | 17176 |
| Country | Sweden |
Conditions
| Sequence: | 52251288 | Sequence: | 52251289 |
| Name | Glioblastoma | Name | Surgical Margin |
| Downcase Name | glioblastoma | Downcase Name | surgical margin |
Id Information
| Sequence: | 40217092 |
| Id Source | org_study_id |
| Id Value | 2019-00100 |
Countries
| Sequence: | 42632022 |
| Name | Sweden |
| Removed | False |
Design Groups
| Sequence: | 55683033 |
| Title | Glioblastoma |
| Description | No intervention. Observation of diffuse reflectance spectroscopy patterna are made on ex-vivo tissue samples in patients undergoing surgery for glial tumors. |
Interventions
| Sequence: | 52564234 |
| Intervention Type | Procedure |
| Name | Diffuse Reflectance Spectroscopy |
| Description | Measurements of DRS patterns in extirpated tumor and cerebral tissue |
Design Outcomes
| Sequence: | 177672270 |
| Outcome Type | primary |
| Measure | DRS pattern |
| Time Frame | simultaneously with surgery |
| Description | Diffuse Reflectance Spectroscopy pattern in tissue type |
Browse Conditions
| Sequence: | 193793259 | Sequence: | 193793260 | Sequence: | 193793261 | Sequence: | 193793262 | Sequence: | 193793263 | Sequence: | 193793264 | Sequence: | 193793265 | Sequence: | 193793266 | Sequence: | 193793267 | Sequence: | 193793268 |
| Mesh Term | Glioblastoma | Mesh Term | Astrocytoma | Mesh Term | Glioma | Mesh Term | Neoplasms, Neuroepithelial | Mesh Term | Neuroectodermal Tumors | Mesh Term | Neoplasms, Germ Cell and Embryonal | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms, Nerve Tissue |
| Downcase Mesh Term | glioblastoma | Downcase Mesh Term | astrocytoma | Downcase Mesh Term | glioma | Downcase Mesh Term | neoplasms, neuroepithelial | Downcase Mesh Term | neuroectodermal tumors | Downcase Mesh Term | neoplasms, germ cell and embryonal | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms, nerve tissue |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48394541 | Sequence: | 48394542 |
| Agency Class | OTHER | Agency Class | INDUSTRY |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | Karolinska University Hospital | Name | Philips Healthcare |
Overall Officials
| Sequence: | 29328999 |
| Role | Principal Investigator |
| Name | Oscar Persson, MD, PhD |
| Affiliation | Karolinska University Hospital |
Design Group Interventions
| Sequence: | 68257259 |
| Design Group Id | 55683033 |
| Intervention Id | 52564234 |
Eligibilities
| Sequence: | 30812130 |
| Sampling Method | Non-Probability Sample |
| Gender | All |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Population | All patients undergoing surgical resection of glial tumors or non-neoplastic cerebral lesions at Karolinska University Hospital |
| Criteria | Inclusion Criteria: Patients undergoing surgical resection of glial tumor or epileptic focus Exclusion Criteria: Unable to give informed consent |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254051283 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Actual Duration | 44 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Number Of Primary Outcomes To Measure | 1 |
Designs
| Sequence: | 30558105 |
| Observational Model | Cohort |
| Time Perspective | Cross-Sectional |
Responsible Parties
| Sequence: | 28924494 |
| Responsible Party Type | Principal Investigator |
| Name | Oscar Persson |
| Title | MD, PhD |
| Affiliation | Karolinska University Hospital |