Cranial Soft TissueNCT01924338
Validation of a Method to Measure Soft Tissue Thickness Using Near Infrared Laser Light
A study testing MRI scan, Laser scan and Dental cast creation in people with Cranial Soft Tissue, run by Dr. Floris Ernst at 2 sites in Germany.
Trial summary
The study is intended to verify a newly developed method to measure the thickness of cranial soft tissue. In the study, a high-resolution MRI scan is used as ground truth for a laser scan of the forehead. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cranial Soft Tissue
- What is being tested?
- MRI scan, Laser scan and Dental cast creation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2013to Feb 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male and female adults
- variations in skin type (at least 10 subjects with skin types I \& II, at least 2 subjects with skin type III, at least 3 subjects with skin type IV, at least 3 subjects with skin types V \& VI)
- optional: availability of high-resolution CT or CBCT (cone-beam CT) scan of the forehead
Who cannot join
- allergies or intolerances against ABS (acrylonitrile butadiene styrene), PMMA (polymethyl methacrylate) or alginate
- elevated light sensitivity of the skin
- exclusion criteria for MRI (claustrophobia, motoric disorders, tattoos, body piercings, metallic implants in the skull, epilepsy, cardiac pacemakers)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 1 recruiting
- Active, not recruiting
Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23562
- Recruiting
University of Luebeck, Institute for Robotics
Lübeck, Schleswig-Holstein, 23562
Floris Ernst, PhD, +494515005208, ernst@rob.uni-luebeck.de
Floris Ernst, PhD
About this study
Official title: Validierung Der Bestimmung Der Gewebedicke Mit Hilfe Von Licht im Infrarotbereich
The study is intended to verify a newly developed method to measure the thickness of cranial soft tissue. In the study, a high-resolution MRI scan is used as ground truth for a laser scan of the forehead. The laser scan is acquired point by point with a prototype scanning unit developed at the University of Luebeck's Institute for Robotics.
The measured tissue thickness using the near-infrared scanning approach is validated against the ground truth obtained by the MRI scan. The average accuracy of the reconstruction method is then computed over all subjects from the individual study arms.
Read more
The required laser intensity and exposure time as well as the achieved measurement accuracy is evaluated with respect to the different skin types of the test subjects. Correlation between these features and the skin type according to the Fitzpatrick scale will be computed.
For 1/3 of the subjects, the laser and MRI scans are repeated after 2 and 8 weeks. The results of the scans are compared and time dependency is analysed.
- Conditions
- Cranial Soft Tissue
- Being tested
- MRI scan, Laser scan, Dental cast creation
- Keywords
- Patient, localisation, in cranial, radiation, therapy, thickness of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDevice
Acquisition of a high-resolution MRI scan (0.15 x 0.15 x 1.0 mm³) aligned with the AC-PC (anterior commissure-posterior commissure) line
Laser scanDevice
A near-infrared laser scan of the subject's forehead is acquired
Dental cast creationProcedure or surgery
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
| Study group | Role | What they receive |
|---|---|---|
| Skin types I and II | Experimental | Volunteers classified as skin types I and II according to the Fitzpatrick Scale
Procedures: dental cast creation, MRI scan, laser scan Receives: Device: MRI scan; Device: Laser scan; Procedure: Dental cast creation |
| Skin type III | Experimental | Volunteers classified as skin type III according to the Fitzpatrick Scale
Procedures: dental cast creation, MRI scan, laser scan Receives: Device: MRI scan; Device: Laser scan; Procedure: Dental cast creation |
| Skin type IV | Experimental | Volunteers classified as skin type IV according to the Fitzpatrick Scale
Procedures: dental cast creation, MRI scan, laser scan Receives: Device: MRI scan; Device: Laser scan; Procedure: Dental cast creation |
| Skin types V and VI | Experimental | Volunteers classified as skin types V and VI according to the Fitzpatrick Scale
Procedures: dental cast creation, MRI scan, laser scan Receives: Device: MRI scan; Device: Laser scan; Procedure: Dental cast creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average accuracy of tissue thickness measurement method [mm]
Measured: up to 6 months
Secondary outcomes (6)
System dependency on skin color - required intensity
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity [mW])
Measured: up to 6 months
Long-term stability of measured features - accuracy
Change in measurement accuracy [mm]
Measured: up to 8 months
Long-term stability of measured features - required intensity
Change in required laser intensity [mW]
Measured: up to 8 months
Long-term stability of measured features - required exposure time
Change in required exposure time [ms]
Measured: up to 8 months
System dependency on skin color - accuracy
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (accuracy of tissue thickness measurement [mm])
Measured: up to 6 months
System dependency on skin color - exposure time
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms])
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (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 Cranial Soft TissueStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Floris Ernst
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems, University of Luebeck
- Responsible party
- Sponsor-investigator, Dr. Floris Ernst, University of Luebeck
- Investigators
- Floris Ernst, PhD, Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924338
- Sponsor's protocol ID
- ROB-NIRMR-001
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2013
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wissel T, Bruder R, Schweikard A, Ernst F. Estimating soft tissue thickness from light-tissue interactions--a simulation study. Biomed Opt Express. 2013 Jun 14;4(7):1176-87. doi: 10.1364/BOE.4.001176. Print 2013 Jul 1.
PubMed 23847741
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validierung Der Bestimmung Der Gewebedicke Mit Hilfe Von Licht im Infrarotbereich
- ClinicalTrials.gov ID
- NCT01924338
- Acronym / sponsor ID
- ROB-NIRMR-001
- Conditions
- Cranial Soft Tissue
- Keywords
- Patient, localisation, in cranial, radiation, therapy, thickness of
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Dr. Floris ErnstUniversity, hospital or other
- Collaborators
- Varian Medical Systems, University of Luebeck
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 16 Aug 2013 (estimated)
- 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.
The study is intended to verify a newly developed method to measure the thickness of cranial soft tissue. In the study, a high-resolution MRI scan is used as ground truth for a laser scan of the forehead. The laser scan is acquired point by point with a prototype scanning unit developed at the University of Luebeck's Institute for Robotics.
The measured tissue thickness using the near-infrared scanning approach is validated against the ground truth obtained by the MRI scan. The average accuracy of the reconstruction method is then computed over all subjects from the individual study arms.
The required laser intensity and exposure time as well as the achieved measurement accuracy is evaluated with respect to the different skin types of the test subjects. Correlation between these features and the skin type according to the Fitzpatrick scale will be computed.
For 1/3 of the subjects, the laser and MRI scans are repeated after 2 and 8 weeks. The results of the scans are compared and time dependency is analysed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Skin types I and II | Experimental | Device: MRI scan, Device: Laser scan, Procedure: Dental cast creationVolunteers classified as skin types I and II according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
| Skin type III | Experimental | Device: MRI scan, Device: Laser scan, Procedure: Dental cast creationVolunteers classified as skin type III according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
| Skin type IV | Experimental | Device: MRI scan, Device: Laser scan, Procedure: Dental cast creationVolunteers classified as skin type IV according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
| Skin types V and VI | Experimental | Device: MRI scan, Device: Laser scan, Procedure: Dental cast creationVolunteers classified as skin types V and VI according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male and female adults
- variations in skin type (at least 10 subjects with skin types I \& II, at least 2 subjects with skin type III, at least 3 subjects with skin type IV, at least 3 subjects with skin types V \& VI)
- optional: availability of high-resolution CT or CBCT (cone-beam CT) scan of the forehead
Key exclusion criteria (3 listed)
- allergies or intolerances against ABS (acrylonitrile butadiene styrene), PMMA (polymethyl methacrylate) or alginate
- elevated light sensitivity of the skin
- exclusion criteria for MRI (claustrophobia, motoric disorders, tattoos, body piercings, metallic implants in the skull, epilepsy, cardiac pacemakers)
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 |
|---|---|---|
| MRI scanAcquisition of a high-resolution MRI scan (0.15 x 0.15 x 1.0 mm³) aligned with the AC-PC (anterior commissure-posterior commissure) line | Device | Skin type III, Skin type IV, Skin types I and II, Skin types V and VI |
| Laser scanA near-infrared laser scan of the subject's forehead is acquired | Device | Skin type III, Skin type IV, Skin types I and II, Skin types V and VI |
| Dental cast creationA dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created | Procedure or surgery | Skin type III, Skin type IV, Skin types I and II, Skin types V and VI |
Primary outcome
Average accuracy of tissue thickness measurement method [mm]
Time frame: up to 6 months
6 secondary outcomes
System dependency on skin color - required intensity
Time frame: up to 6 months
Long-term stability of measured features - accuracy
Time frame: up to 8 months
Long-term stability of measured features - required intensity
Time frame: up to 8 months
Long-term stability of measured features - required exposure time
Time frame: up to 8 months
System dependency on skin color - accuracy
Time frame: up to 6 months
System dependency on skin color - exposure time
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Background: PubMed 23847741Wissel T, Bruder R, Schweikard A, Ernst F. Estimating soft tissue thickness from light-tissue interactions--a simulation study. Biomed Opt Express. 2013 Jun 14;4(7):1176-87. doi: 10.1364/BOE.4.001176. Print 2013 Jul 1.
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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.
Floris Ernst, PhD principal investigator
University of Luebeck
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan, Laser scan and Dental cast creation in people with Cranial Soft Tissue, run by Dr. Floris Ernst 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 3 inclusion and 3 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 21 Aug 2014. 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 Floris Ernst, PhD (+494515005208, ernst@rob.uni-luebeck.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average accuracy of tissue thickness measurement method [mm] (time frame: up to 6 months). 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 NCT01924338, 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 21 Aug 2014.