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NCT Number: NCT06716892

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multispectral Optoacoustic Tomography (MSOT)

Device

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

Primary outcomes

  1. Muscle oxygenation (in arbitrary units)

    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.

  2. Quantitative hemoglobin-associated signal (in arbitrary units)

    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.

Secondary outcomes

  1. Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure)

    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).

  2. Oxygen saturation (in %)

    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

  3. Questionnaire items (Age, sex, height, weight, BMI, skin type, pre-existing conditions, medication, substance abuse [alcohol, nicotine], moderate physical activity per week)

    Time frame: Once at the date of inclusion for the study.

    Questionnaire items for both the healthy and the head and neck tumor cohort.

  4. Muscle oxygenation (in arbitrary units)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Wachter

CONTACT

[email protected]

+49 9131 85 41175

Jonas Wolf, Dr. med.

CONTACT

[email protected]

+49 9131 85 43770

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: msotcmfflap

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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