|- candidate number||15314|
|- NTR Number||NTR4125|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-aug-2013|
|- Secondary IDs||LOW-MSOT1.0 |
|- Public Title||MSOT beeldvorming in de onderbenen van gezonde vrijwilligers.|
|- Scientific Title||Non-invasive imaging of perfusion and oxygenation of the LOWer extremities in healthy volunteers by means of MultiSpectral Optoacoustic Tomography (LOW-MSOT) |
|- hypothesis||Evalueren wat de gevoeligheid van de MSOT techniek is voor het meten van de doorbloeding en de hoeveelheid zuurstof in de onderbenen van gezonde vrijwilligers|
|- Healt Condition(s) or Problem(s) studied||Peripheral atheroslerosis|
|- Inclusion criteria||Ten (10) healthy volunteers (5 males and 5 females), age >18 years will be asked to participate. |
- No prior or current medication.
- Age >= 18 years.
- Written informed consent.
- Adequate potential for telephone follow-up 14 days following the measurement with MSOT.
|- Exclusion criteria||- Medical or psychiatric conditions that compromise the volunteers' ability to give informed consent. |
- Concurrent uncontrolled medical conditions.
- Any investigational treatment for peripheral vascular disease or lower leg fractures within the past month.
- Pregnancy or breast feeding.
- Clinically significant (i.e. active) cardiovascular disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication, peripheral vascular disease) or myocardial infarction within the past 12 months.
- Patients with symptoms or history of peripheral neuropathy.
- (Partial) amputation of one of the legs.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2013|
|- planned closingdate||1-dec-2013|
|- Target number of participants||10|
|- Interventions||Measurement variation (mean and SD) of MSOT in the lower leg.
Correlation of MSOT oxygenation and perfusion measurements with standard ultrasound imaging of the fixed anatomical landmarks, pulse-oximetry data for oxygenation status at the hallux and the ankle-brachial index of the right lower leg.
|- Primary outcome||Primary endpoints are to determine measurement variation (mean and SD) of MSOT in physiological perfused lower leg. |
|- Secondary outcome||Information on safety aspects of the MSOT imaging device, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR). |
|- Timepoints||One time-point measurement after obtaining informed consent|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. G.M. Dam, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G.M. Dam, van|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary||The current project comprises a proof of principal study to test the technical feasability of the use of Multispectral Optoacoustic Tomography (MSOT) in healthy volunteers for non-invasive measurements and imaging of perfusion and oxygenation in the lower legs. MSOT is a non-invasive imaging modality that provides real-time quantifiable in vivo visualizations dependent on the intrinsic difference in optical absorption properties of tissues. MSOT uses pulsed laser light of various wavelengths to excitate the molecules in tissue. The excitated molecules generate a ultrasonic wave, which is detected by an ultrasonic detector. Unlike optical microscopy, optoacoustic imaging is not influenced significantly by light scattering in tissue, because it detects ultrasonic waves. This results in the ability to maintain a high resolution and quantifiability even at depths of 1.5-2 cm. The imaging system is essentially a laser and an ultrasound detector combined in a handheld probe which is connected to a computer for processing, and a display for real-time video-rate visualisation. By measuring peripheral blood oxygenation and perfusion with a prototype handheld MSOT probe and comparing that to standard ultrasound imaging, pulse-oximetry and standard ankle-brachial index as a gold standard, the diagnostic accuracy and measurement ranges in physiologic conditions as determined by MSOT will be tested.|
|- Main changes (audit trail)|
|- RECORD||24-aug-2013 - 2-sep-2013|