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

NCT06716892 | Recruiting

• 1 other identifier: 24-335-B
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Cancer; Healthy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  Postoperative observation of the free flap within the stationary visit until dismission (14 days)

• 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.

• 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.

• 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.

Study Arms (2)

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)

Head and neck cancer patients.

Patients with histopathological diagnosed head and neck cancer.

Device: Multispectral Optoacoustic Tomography (MSOT)

Interventions

Multispectral Optoacoustic Tomography (MSOT) DEVICE

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

Head and neck cancer patients.; Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood samples

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Felix Wachter

CONTACT

+49 9131 85 41175; felix.wachter@uk-erlangen.de

Jonas Wolf, Dr. med.

CONTACT

+49 9131 85 43770; jonas.wolf@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: November 28, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)