Head and Neck CancerNCT04437030
Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
A study testing MSOT Acuity Echo device in people with Head and Neck Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Multispectral photoacoustic imaging enables the measurement of the optical absorption of various tissue components or exogenous contrast agents in vivo. The dominant, near infrared absorbing chromophores in human tissue are oxy- and deoxyhemoglobin followed by collagen, melanin and lipids. 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
- What is being tested?
- MSOT Acuity Echo device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jul 2020to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Willingness and ability to participate
- sufficient knowledge of German to understand the patient / subject information and the declaration of consent,
- tumor disease to be treated by radiotherapy in the neck and neck area,
- Completed wound healing after operative interventions in the head and neck area,
- The patient's consent and written consent,
- the patient's ability to assess the nature and scope as well as possible consequences of the clinical study,
- 8. Age ≥ 18 years.
- Requirement 3 does not apply to the control group of healthy subjects
Who cannot join
- Pre-radiation in the head and neck area
- Inadequate regression of toxicities from previous therapies
- Indications that the participant is unlikely to adhere to the study protocol (e.g. lack of compliance)
- Missing written declaration of consent
Trial locations and contacts
1 site in 1 country.
About this study
Multispectral photoacoustic imaging enables the measurement of the optical absorption of various tissue components or exogenous contrast agents in vivo. The dominant, near infrared absorbing chromophores in human tissue are oxy- and deoxyhemoglobin followed by collagen, melanin and lipids. The multispectral measurement of the absorption of hemoglobin shows changes in blood oxygen saturation and blood volume. The high resolution of photoacoustic imaging also enables the vascular structure to be displayed. The aim of this exploratory study is to generate hypotheses by applying photoacoustic imaging to the field of head and neck tumor therapy. The next step is to investigate whether and how photoacoustic imaging can help improve diagnostics and better planning of treatments in the future. In particular, the differences between normal and tumor tissue and the changes in the tissue due to radiation therapy using photoacoustic imaging are examined. In the quantitative analysis of the images, measured chromophores, primarily oxygen saturation, blood volume and collagen concentrations at different measuring points are used in the course of the therapy.
Read the detailed description
Multispectral photoacoustics enable non-invasive, inexpensive and dose-free real-time imaging of light-absorbing molecules (absorbers), e.g. Deoxyhemoglobin and oxygenated hemoglobin in human tissue. This allows blood oxygen saturation (sO2) to be determined at depths of up to several centimeters. Measurements of correlates to blood volume and collagen concentration are also made possible. In photoacoustic imaging, the tissue to be examined is irradiated with nanosecond short, near-infrared (650 - 1300nm) laser pulses. If laser light is locally absorbed by a tissue structure, it expands thermoelastically, which triggers an ultrasonic pressure wave, which is measured with the aid of an ultrasonic head. The initial pressure distribution and thus the absorption in the tissue can then be reconstructed. Since different molecules show distinct absorption behavior depending on the wavelength in the near infrared, by acquiring several wavelengths it is possible to estimate which absorbers are in which concentration in a tissue structure. The effectiveness and tolerability of modern high-precision radiation therapy for head and neck tumors largely depends on the quality of the imaging. The potential diagnostic benefits of photoacoustics in the radiotherapy of patients with head and neck tumors principally concern the target volume definition, the implementation of image-guided, adaptive radiotherapy and imaging tumor follow-up as well as the early detection of tumors.
Multispectral photoacoustics primarily enable the analysis of tumor hypoxia, which has been associated several times with increased radio resistance and an unfavorable prognosis. In addition, other factors, e.g. the blood volume and the collagen content in the tissue are analyzed.
- Conditions
- Head and Neck Cancer
- Being tested
- MSOT Acuity Echo device
- 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.
MSOT Acuity Echo deviceDevice
The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Active comparator | Patient with Head and neck cancer Receives: Device: MSOT Acuity Echo device |
| Healthy subjects | Other | Healty subjects with not history of Tumor disease in the Head and neck region Receives: Device: MSOT Acuity Echo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Measurement of Oxygen Saturation in the tumor tissue
Measured: previouse to Radiotherapy start
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Measurement of Oxygen Saturation in the tumor tissue
Measured: 3 weeks after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Measurement of Oxygen Saturation in the tumor tissue
Measured: 3 month after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: blood volume
blood volume
Measured: previouse to Radiotherapy start
diagnostic feasibility of photoacoustic imaging: blood volume
blood volume
Measured: 3 weeks after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: blood volume
blood volume
Measured: 3 month after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: blood volume
amount of collagen in the tumor tissue
Measured: previouse to Radiotherapy start
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
amount of collagen in the tumor tissue
Measured: 3 weeks after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
amount of collagen in the tumor tissue
Measured: 3 month after Radiotherapy start
Secondary outcomes (12)
Analysis of Tumor tissue and normal tissue
Differences of Oxygen saturation
Measured: previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue
Differences of Oxygen saturation
Measured: 3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue
Differences of Oxygen saturation
Measured: 3 month after Radiotherapy start
Analysis of Tumor tissue and normal tissue
blood volume
Measured: previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue
blood volume
Measured: 3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue
blood volume
Measured: 3 month after Radiotherapy start
Analysis of Tumor tissue and normal tissue
amount of collagen
Measured: previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue
amount of collagen
Measured: 3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue
amount of collagen
Measured: 3 month after Radiotherapy start
multimodal information about tissue morphology
Registration of photoaccustic and MRI/CT Imaging
Measured: previouse to Radiotherapy start
multimodal information about tissue function
Registration of photoaccustic and MRI/CT Imaging
Measured: 3 weeks after Radiotherapy start
multimodal information about tissue function
Registration of photoaccustic and MRI/CT Imaging
Measured: 3 month after Radiotherapy start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start9 Jul 2020
- Primary completion1 Jan 2022
- Study completion1 Jul 2023
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 Hospital HeidelbergThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Sebastian Adeberg, PD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437030
- Sponsor's protocol ID
- MSOT HNC
- Status last verified
- Jan 2024
- First submitted
- 9 Jun 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT04437030
- Acronym / sponsor ID
- MSOT HNC
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 18 Jun 2020 (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 photoacoustic imaging enables the measurement of the optical absorption of various tissue components or exogenous contrast agents in vivo. The dominant, near infrared absorbing chromophores in human tissue are oxy- and deoxyhemoglobin followed by collagen, melanin and lipids. The multispectral measurement of the absorption of hemoglobin shows changes in blood oxygen saturation and blood volume. The high resolution of photoacoustic imaging also enables the vascular structure to be displayed. The aim of this exploratory study is to generate hypotheses by applying photoacoustic imaging to the field of head and neck tumor therapy. The next step is to investigate whether and how photoacoustic imaging can help improve diagnostics and better planning of treatments in the future. In particular, the differences between normal and tumor tissue and the changes in the tissue due to radiation therapy using photoacoustic imaging are examined. In the quantitative analysis of the images, measured chromophores, primarily oxygen saturation, blood volume and collagen concentrations at different measuring points are used in the course of the therapy.
Detailed description
Multispectral photoacoustics enable non-invasive, inexpensive and dose-free real-time imaging of light-absorbing molecules (absorbers), e.g. Deoxyhemoglobin and oxygenated hemoglobin in human tissue. This allows blood oxygen saturation (sO2) to be determined at depths of up to several centimeters. Measurements of correlates to blood volume and collagen concentration are also made possible. In photoacoustic imaging, the tissue to be examined is irradiated with nanosecond short, near-infrared (650 - 1300nm) laser pulses. If laser light is locally absorbed by a tissue structure, it expands thermoelastically, which triggers an ultrasonic pressure wave, which is measured with the aid of an ultrasonic head. The initial pressure distribution and thus the absorption in the tissue can then be reconstructed. Since different molecules show distinct absorption behavior depending on the wavelength in the near infrared, by acquiring several wavelengths it is possible to estimate which absorbers are in which concentration in a tissue structure. The effectiveness and tolerability of modern high-precision radiation therapy for head and neck tumors largely depends on the quality of the imaging. The potential diagnostic benefits of photoacoustics in the radiotherapy of patients with head and neck tumors principally concern the target volume definition, the implementation of image-guided, adaptive radiotherapy and imaging tumor follow-up as well as the early detection of tumors.
Multispectral photoacoustics primarily enable the analysis of tumor hypoxia, which has been associated several times with increased radio resistance and an unfavorable prognosis. In addition, other factors, e.g. the blood volume and the collagen content in the tissue are analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Active comparator | Device: MSOT Acuity Echo devicePatient with Head and neck cancer |
| Healthy subjects | Other | Device: MSOT Acuity Echo deviceHealty subjects with not history of Tumor disease in the Head and neck region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willingness and ability to participate
- sufficient knowledge of German to understand the patient / subject information and the declaration of consent,
- tumor disease to be treated by radiotherapy in the neck and neck area,
- Completed wound healing after operative interventions in the head and neck area,
- The patient's consent and written consent,
Key exclusion criteria (4 listed)
- Pre-radiation in the head and neck area
- Inadequate regression of toxicities from previous therapies
- Indications that the participant is unlikely to adhere to the study protocol (e.g. lack of compliance)
- Missing written declaration of consent
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 |
|---|---|---|
| MSOT Acuity Echo deviceThe MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings. | Device | Healthy subjects, Patient |
Primary outcome
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Time frame: previouse to Radiotherapy start
Measurement of Oxygen Saturation in the tumor tissue
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Time frame: 3 weeks after Radiotherapy start
Measurement of Oxygen Saturation in the tumor tissue
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Time frame: 3 month after Radiotherapy start
Measurement of Oxygen Saturation in the tumor tissue
diagnostic feasibility of photoacoustic imaging: blood volume
Time frame: previouse to Radiotherapy start
blood volume
diagnostic feasibility of photoacoustic imaging: blood volume
Time frame: 3 weeks after Radiotherapy start
blood volume
diagnostic feasibility of photoacoustic imaging: blood volume
Time frame: 3 month after Radiotherapy start
blood volume
diagnostic feasibility of photoacoustic imaging: blood volume
Time frame: previouse to Radiotherapy start
amount of collagen in the tumor tissue
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
Time frame: 3 weeks after Radiotherapy start
amount of collagen in the tumor tissue
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
Time frame: 3 month after Radiotherapy start
amount of collagen in the tumor tissue
12 secondary outcomes
Analysis of Tumor tissue and normal tissue
Time frame: previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue
Time frame: 3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue
Time frame: 3 month after Radiotherapy start
Analysis of Tumor tissue and normal tissue
Time frame: previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue
Time frame: 3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue
Time frame: 3 month after Radiotherapy start
Analysis of Tumor tissue and normal tissue
Time frame: previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue
Time frame: 3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue
Time frame: 3 month after Radiotherapy start
multimodal information about tissue morphology
Time frame: previouse to Radiotherapy start
multimodal information about tissue function
Time frame: 3 weeks after Radiotherapy start
multimodal information about tissue function
Time frame: 3 month after Radiotherapy start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sebastian Adeberg, PD principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSOT Acuity Echo device in people with Head and Neck Cancer, run by University Hospital Heidelberg 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 8 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: finished, as of the sponsor's last update on 5 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation (time frame: previouse to Radiotherapy start). The study lists 9 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 5 Jan 2024.