Evaluation of 3D Ultrasound in Brain Tumor Surgery (Neuro3DUS)
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. |
ClinicalTrials.gov Identifier: NCT05956977 |
Recruitment Status :
Recruiting
First Posted : July 24, 2023
Last Update Posted : July 24, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Residual Tumor | Device: resection with help of 3D ultrasound | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | retrospective matched pair control |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of 3D Ultrasound in Brain Tumor Surgery |
Actual Study Start Date : | October 1, 2021 |
Estimated Primary Completion Date : | December 1, 2024 |
Estimated Study Completion Date : | March 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: prospective arm
Use of 3D ultrasound intraoperative before intraoperative MRI
|
Device: resection with help of 3D ultrasound
see above |
No Intervention: retrospective matched pair arm
no use of intraoperative ultrasound before intraoperative MRI
|
- Extent of resection [ Time Frame: 48 hours after surgery ]Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.
- image quality [ Time Frame: during surgery ]ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).
- neurological outcome [ Time Frame: both after surgery and at 3 months ]both at discharge and at 3 months follow up using NIHSS Score
- Accuracy of device [ Time Frame: during surgery ]ultrasound image acuracy compared to preoperative MRI, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst), including rating of brainshift and navigation inaccuracy.
- brainshift during surgery [ Time Frame: during surgery ]brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion
Exclusion Criteria:
- no ability for informed consent
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 ClinicalTrials.gov identifier (NCT number): NCT05956977
Contact: Jan Coburger, apl. Prof. Dr. med. | 0822196 ext 28858 | jan.coburger@uni-ulm.de | |
Contact: Christian R Wirtz, Prof. Dr. med. | 0822196 ext 0 |
Germany | |
University of Tübingen | Recruiting |
Tübingen, Baden Würtemberg, Germany | |
Contact: Constantin Roder, Prof. Dr. me.d | |
University of Ulm | Recruiting |
Ulm, Germany | |
Contact: Jan Coburger, MD jan.coburger@uni-ulm.de |
Responsible Party: | Jan Coburger, apl. Prof. Dr. med. Jan Coburger, Consultant, University of Ulm |
ClinicalTrials.gov Identifier: | NCT05956977 |
Other Study ID Numbers: |
Neuro3DUS |
First Posted: | July 24, 2023 Key Record Dates |
Last Update Posted: | July 24, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasm, Residual Neoplasms Neoplastic Processes Pathologic Processes |