Head and Neck CancermsotcmfflapNCT06716892
Non-invasive Preoperative Tissue Evaluation in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)
An observational study of Head and Neck Cancer and Healthy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Healthy
- What is being tested?
- Multispectral Optoacoustic Tomography (MSOT)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 28 Nov 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Cohort 1: Histopathological diagnosed head and neck tumor patients.
- Cohort 2: Healthy adults.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, Bavaria, 91054
Felix Wachter, +49 9131 85 41175, felix.wachter@uk-erlangen.de
Jonas Wolf, Dr. med., +49 9131 85 43770, jonas.wolf@uk-erlangen.de
About this study
Official title: 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).
- Conditions
- Head and Neck Cancer, Healthy
- Being tested
- Multispectral Optoacoustic Tomography (MSOT)
- Keywords
- MSOT, Head and neck cancer, healthy, flap surgery, graft, perfusion, oxygenation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic Tomography (MSOT)Device
Non-invasive transcutaneous MSOT imaging of muscle and subcutaneos regions.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| Head and neck cancer patients. | Patients with histopathological diagnosed head and neck cancer. Receives: Device: Multispectral Optoacoustic Tomography (MSOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle oxygenation (in arbitrary units)
Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.
Measured: 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.
Measured: 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)
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).
Measured: 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
Measured: 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.
Measured: Once at the date of inclusion for the study.
Muscle oxygenation (in arbitrary units)
Oxygenated hemoglobin signal in the measured muscle regions in all different cohorts.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start28 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716892
- Sponsor's protocol ID
- 24-335-B
- Acronym
- msotcmfflap
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the big amounts of acquired image data a publishing is not feasable.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Preoperative Donor-site Evaluation of Free Flaps in Head and Neck Tumor Patients Using Multispectral Optoacoustic Tomography (MSOT)
- ClinicalTrials.gov ID
- NCT06716892
- Acronym / sponsor ID
- msotcmfflap / 24-335-B
- Conditions
- Head and Neck Cancer, Healthy
- Keywords
- MSOT, Head and neck cancer, healthy, flap surgery, graft, perfusion, oxygenation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: Multispectral Optoacoustic Tomography (MSOT)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) |
| Head and neck cancer patients. | – | Device: Multispectral Optoacoustic Tomography (MSOT)Patients with histopathological diagnosed head and neck cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Cohort 1: Histopathological diagnosed head and neck tumor patients.
- Cohort 2: Healthy adults.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacoustic Tomography (MSOT)Non-invasive transcutaneous MSOT imaging of muscle and subcutaneos regions. | Device | Head and neck cancer patients., Healthy |
Primary outcome
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.
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.
4 secondary outcomes
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)
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No. Due to the big amounts of acquired image data a publishing is not feasable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Healthy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Wachter (+49 9131 85 41175, felix.wachter@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.