Residual TumorNeuro3DUSNCT05956977
Evaluation of 3D Ultrasound in Brain Tumor Surgery
A study testing resection with help of 3D ultrasound in people with Residual Tumor, run by University of Ulm at 2 sites in Germany.
Trial summary
Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Tumor
- What is being tested?
- resection with help of 3D ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2021to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion
Who cannot join
- no ability for informed consent
Trial locations and contacts
2 sites in 1 country.
Christian R Wirtz, Prof. Dr. med. contact
Germany2 sites, 2 recruiting
- Recruiting
University of Tübingen
Tübingen, Baden Würtemberg
Constantin Roder, Prof. Dr. me.d
- Recruiting
University of Ulm
Ulm
Jan Coburger, MD, jan.coburger@uni-ulm.de
About this study
Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort.
- Conditions
- Residual Tumor
- Being tested
- resection with help of 3D ultrasound
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection with help of 3D ultrasoundDevice
see above
| Study group | Role | What they receive |
|---|---|---|
| prospective arm | Experimental | Use of 3D ultrasound intraoperative before intraoperative MRI Receives: Device: resection with help of 3D ultrasound |
| retrospective matched pair arm | No intervention | no use of intraoperative ultrasound before intraoperative MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of resection
Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.
Measured: 48 hours after surgery
Secondary outcomes (3)
image quality
ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).
Measured: during surgery
neurological outcome
both at discharge and at 3 months follow up using NIHSS Score
Measured: both after surgery and at 3 months
Accuracy of device
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.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Oct 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Residual TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- retrospective matched pair control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Brainlab AG
- Responsible party
- Principal investigator, Jan Coburger, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956977
- Sponsor's protocol ID
- Neuro3DUS
- Acronym
- Neuro3DUS
- Status last verified
- Jul 2023
- First submitted
- 24 Apr 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aleo D, Elshaer Z, Pfnur A, Schuler PJ, Fontanella MM, Wirtz CR, Pala A, Coburger J. Evaluation of a Navigated 3D Ultrasound Integration for Brain Tumor Surgery: First Results of an Ongoing Prospective Study. Curr Oncol. 2022 Sep 15;29(9):6594-6609. doi: 10.3390/curroncol29090518.
PubMed 36135087
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Ultrasound in Brain Tumor Surgery
- ClinicalTrials.gov ID
- NCT05956977
- Acronym / sponsor ID
- Neuro3DUS / Neuro3DUS
- Conditions
- Residual Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Brainlab AG
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- retrospective matched pair control
| Arm | Type | Receives |
|---|---|---|
| prospective arm | Experimental | Device: resection with help of 3D ultrasoundUse of 3D ultrasound intraoperative before intraoperative MRI |
| retrospective matched pair arm | No intervention | –no use of intraoperative ultrasound before intraoperative MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion
Key exclusion criteria (1 listed)
- no ability for informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resection with help of 3D ultrasoundsee above | Device | prospective arm |
Primary outcome
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.
3 secondary outcomes
image quality
Time frame: during surgery
neurological outcome
Time frame: both after surgery and at 3 months
Accuracy of device
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Results publication: PubMed 36135087Aleo D, Elshaer Z, Pfnur A, Schuler PJ, Fontanella MM, Wirtz CR, Pala A, Coburger J. Evaluation of a Navigated 3D Ultrasound Integration for Brain Tumor Surgery: First Results of an Ongoing Prospective Study. Curr Oncol. 2022 Sep 15;29(9):6594-6609. doi: 10.3390/curroncol29090518.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian R Wirtz, Prof. Dr. med. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resection with help of 3D ultrasound in people with Residual Tumor, run by University of Ulm at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Coburger, apl. Prof. Dr. med. (0822196 ext. 28858, jan.coburger@uni-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of resection (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.