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

Non-invasive Preoperative Donor-site Evaluation of Free Flaps 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).

Study Overview

• Status: Recruiting
• Conditions: Healthy; Head and Neck Cancer
• Intervention / Treatment: Device: Multispectral Optoacoustic Tomography (MSOT)

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Felix Wachter; Phone Number: +49 9131 85 41175; Email: felix.wachter@uk-erlangen.de
• Study Contact Backup: Name: Jonas Wolf, Dr. med.; Phone Number: +49 9131 85 43770; Email: jonas.wolf@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • University Hospital Erlangen
      • Contact: Felix Wachter; Phone Number: +49 9131 85 41175; Email: felix.wachter@uk-erlangen.de
      • Contact: Jonas Wolf, Dr. med.; Phone Number: +49 9131 85 43770; Email: jonas.wolf@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Healthy adult volunteers. Exclusion criteria: Chronical abuse of alcohol and nicotine, pregnancy and breastfeeding, ink / tattoo in the areas of interest (upper back, distal forearm, upper and lower leg)	Device: Multispectral Optoacoustic Tomography (MSOT); Non-invasive transcutaneous MSOT imaging of muscle and subcutaneos regions.
Head and neck cancer patients.; Patients with histopathological diagnosed head and neck cancer.	Device: Multispectral Optoacoustic Tomography (MSOT); Non-invasive transcutaneous MSOT imaging of muscle and subcutaneos regions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle oxygenation (in arbitrary units)	Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.	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.
Quantitative hemoglobin-associated signal (in arbitrary units)	Hemoglobin signal in the measured muscle regions in all different cohorts.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle oxygenation (in arbitrary units)	Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.	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.
Postoperative compromise of microvascular free flaps (Microvascular revision, flap failure)	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).	Postoperative observation of the free flap within the stationary visit until dismission (14 days)
Oxygen saturation (in %)	Proportion of oxygenated hemoglobin signal compared with total hemoglobin signal in the measured muscle regions in all different cohorts	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.
Questionnaire items (Age, sex, height, weight, BMI, skin type, pre-existing conditions, medication, substance abuse [alcohol, nicotine], moderate physical activity per week)	Questionnaire items for both the healthy and the head and neck tumor cohort.	Once at the date of inclusion for the study.

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: oxygenation; healthy; Head and neck cancer; graft; perfusion; MSOT; flap surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 24-335-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the big amounts of acquired image data a publishing is not feasable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No