University Hospital Erlangen
Erlangen, Bavaria, 91054, Germany
Location status: Recruiting
Location contact
Felix Wachter
CONTACT
Jonas Wolf, Dr. med.
CONTACT
NCT Number: NCT06716892
Multispectral Optoacoustic Tomography (MSOT) is a promising imaging technology that utilizes pulsed laser light. One of the key capabilities of this technology is measuring oxygenation within human tissue. This proposed study aims to investigate possible limitations of human tissue used for reconstructive surgery due to flawed tissue perfusion.
Healthy volunteers as well as patients with a diagnosed head and neck cancer entity will be recruited. Both cohorts will then be scanned on different body areas (most common tissue sites used for reconstructive surgery on the back, arms and legs) to assess differences in muscle oxygenation between the healthy and tumor patient cohort using MSOT.
The hypothesis of the study is, that patients with diagnosed head and neck cancer entities are prone to compromised tissue perfusion due to a high prevalence of smoking within the head neck tumor patient cohort and therefore perfusion restirciting diseases e.g. peripheral arterial occlusive disease (PAOD).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Erlangen, Bavaria, 91054, Germany
Location status: Recruiting
Felix Wachter
CONTACT
Jonas Wolf, Dr. med.
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-invasive transcutaneous MSOT imaging of muscle and subcutaneos regions.
Time frame: Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.
Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.
Time frame: Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.
Hemoglobin signal in the measured muscle regions in all different cohorts.
Time frame: Postoperative observation of the free flap within the stationary visit until dismission (14 days)
Correlation between preoperative accquired MSOT parameters (e.g. quantitative hemoglobin-associated signal, muscle oxygenation, oxygen saturation) in the head and neck cancer cohort and the clinical outcome of the reconstructive surgery (Microvascular revision, flap failure).
Time frame: Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.
Proportion of oxygenated hemoglobin signal compared with total hemoglobin signal in the measured muscle regions in all different cohorts
Time frame: Once at the date of inclusion for the study.
Questionnaire items for both the healthy and the head and neck tumor cohort.
Time frame: Immediately before and after intervention (exercise) within both cohorts. Within the cohort of head and neck tumor patients, possible postoperative second measurement of the transplanted tissue after performed reconstructive surgery.
Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.
Contact information is provided by the study sponsor or research team.
Felix Wachter
CONTACT
Jonas Wolf, Dr. med.
CONTACT
University of Erlangen-Nürnberg Medical School
Other
Non-invasive Preoperative Donor-site Evaluation of Free Flaps in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)
Acronym: msotcmfflap
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