Clinical trial NCT06716892: Non-invasive Preoperative Tissue Evaluation in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)
Official title: Non-invasive Preoperative Donor-site Evaluation of Free Flaps in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Healthy
Keywords: MSOT
Head and neck cancer
healthy
flap surgery
graft
perfusion
oxygenation
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects are Histopathological diagnosed head and neck tumor patients of the cmf department of the University clinic of erlangen (1) and healthy volunteers who will be recruited from advertised announcements (2).

All subjects meeting all inclusion and none of the exclusion criteria will be enrolled and added to their corresponding cohort (1 or 2).

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Cohort 1: Histopathological diagnosed head and neck tumor patients.
* Cohort 2: Healthy adults.

Exclusion Criteria:

* Pregnancy / breastfeeding
* ink / tattoo in the areas of interest (upper back, distal forearm, upper and lower leg)
* missing consent form
* Cohort 2: Chronical abuse of alcohol and nicotine.

Primary outcomes:
measure: Muscle oxygenation (in arbitrary units)
timeFrame: 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.
measure: Quantitative hemoglobin-associated signal (in arbitrary units)
timeFrame: 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.
Secondary outcomes:
measure: Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure)
timeFrame: Postoperative observation of the free flap within the stationary visit until dismission (14 days)
measure: Oxygen saturation (in %)
timeFrame: 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.
measure: Questionnaire items (Age, sex, height, weight, BMI, skin type, pre-existing conditions, medication, substance abuse [alcohol, nicotine], moderate physical activity per week)
timeFrame: Once at the date of inclusion for the study.
measure: Muscle oxygenation (in arbitrary units)
timeFrame: 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.
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
state: Bavaria
Study officials:
References: