Validation of a Method to Measure Soft Tissue Thickness Using Near Infrared Laser Light
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.
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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Schleswig-Holstein
-
Lübeck、Schleswig-Holstein、ドイツ、23562
- 積極的、募集していない
- Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein
-
Lübeck、Schleswig-Holstein、ドイツ、23562
- 募集
- University of Luebeck, Institute for Robotics
-
コンタクト:
- Floris Ernst, PhD
- 電話番号:+494515005208
- メール:ernst@rob.uni-luebeck.de
-
主任研究者:
- Floris Ernst, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Skin types I and II
Volunteers classified as skin types I and II according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
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
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
|
実験的:Skin type III
Volunteers classified as skin type III according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
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
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
|
実験的:Skin type IV
Volunteers classified as skin type IV according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
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
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
|
実験的:Skin types V and VI
Volunteers classified as skin types V and VI according to the Fitzpatrick Scale Procedures: dental cast creation, MRI scan, laser scan |
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
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Average accuracy of tissue thickness measurement method [mm]
時間枠:up to 6 months
|
up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
System dependency on skin color - required intensity
時間枠:up to 6 months
|
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity [mW])
|
up to 6 months
|
|
Long-term stability of measured features - accuracy
時間枠:up to 8 months
|
Change in measurement accuracy [mm]
|
up to 8 months
|
|
Long-term stability of measured features - required intensity
時間枠:up to 8 months
|
Change in required laser intensity [mW]
|
up to 8 months
|
|
Long-term stability of measured features - required exposure time
時間枠:up to 8 months
|
Change in required exposure time [ms]
|
up to 8 months
|
|
System dependency on skin color - accuracy
時間枠:up to 6 months
|
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (accuracy of tissue thickness measurement [mm])
|
up to 6 months
|
|
System dependency on skin color - exposure time
時間枠:up to 6 months
|
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time [ms])
|
up to 6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Floris Ernst, PhD、University of Luebeck
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ROB-NIRMR-001
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。