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Non-invasive Preoperative Tissue Evaluation in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)

Non-invasive Preoperative Donor-site Evaluation of Free Flaps in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06716892
Acronym
msotcmfflap
Enrollment
40
Registered
2024-12-04
Start date
2024-11-28
Completion date
2025-07-31
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Healthy

Keywords

MSOT, Head and neck cancer, healthy, flap surgery, graft, perfusion, oxygenation

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).

Interventions

Non-invasive transcutaneous MSOT imaging of muscle and subcutaneos regions.

Sponsors

University of Erlangen-Nürnberg Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle oxygenation (in arbitrary units)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.
Quantitative hemoglobin-associated signal (in arbitrary units)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.

Secondary

MeasureTime frameDescription
Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure)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).
Oxygen saturation (in %)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
Questionnaire items (Age, sex, height, weight, BMI, skin type, pre-existing conditions, medication, substance abuse [alcohol, nicotine], moderate physical activity per week)Once at the date of inclusion for the study.Questionnaire items for both the healthy and the head and neck tumor cohort.
Muscle oxygenation (in arbitrary units)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.

Countries

Germany

Contacts

Primary ContactFelix Wachter
felix.wachter@uk-erlangen.de+49 9131 85 41175
Backup ContactJonas Wolf, Dr. med.
jonas.wolf@uk-erlangen.de+49 9131 85 43770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026