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

NCT ID: NCT06716892

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-28

Study Completion Date

2025-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Head and Neck Cancer Healthy

Keywords

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MSOT Head and neck cancer healthy flap surgery graft perfusion oxygenation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Multispectral Optoacoustic Tomography (MSOT)

Intervention Type DEVICE

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

Head and neck cancer patients.

Patients with histopathological diagnosed head and neck cancer.

Multispectral Optoacoustic Tomography (MSOT)

Intervention Type DEVICE

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

Interventions

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Multispectral Optoacoustic Tomography (MSOT)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Erlangen

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Felix Wachter

Role: CONTACT

Phone: +49 9131 85 41175

Email: [email protected]

Jonas Wolf, Dr. med.

Role: CONTACT

Phone: +49 9131 85 43770

Email: [email protected]

Facility Contacts

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Felix Wachter

Role: primary

Jonas Wolf, Dr. med.

Role: backup

Other Identifiers

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24-335-B

Identifier Type: -

Identifier Source: org_study_id