Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
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ClinicalTrials.gov Identifier: NCT04437030 |
Recruitment Status :
Recruiting
First Posted : June 18, 2020
Last Update Posted : April 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Device: MSOT Acuity Echo device | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors |
Actual Study Start Date : | July 9, 2020 |
Estimated Primary Completion Date : | January 1, 2022 |
Estimated Study Completion Date : | July 1, 2023 |

Arm | Intervention/treatment |
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Active Comparator: Patient
Patient with Head and neck cancer
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Device: MSOT Acuity Echo device
The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings. |
Healthy subjects
Healty subjects with not history of Tumor disease in the Head and neck region
|
Device: MSOT Acuity Echo device
The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings. |
- 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
- Analysis of Tumor tissue and normal tissue [ Time Frame: previouse to Radiotherapy start ]Differences of Oxygen saturation
- Analysis of Tumor tissue and normal tissue [ Time Frame: 3 weeks after Radiotherapy start ]Differences of Oxygen saturation
- Analysis of Tumor tissue and normal tissue [ Time Frame: 3 month after Radiotherapy start ]Differences of Oxygen saturation
- Analysis of Tumor tissue and normal tissue [ Time Frame: previouse to Radiotherapy start ]blood volume
- Analysis of Tumor tissue and normal tissue [ Time Frame: 3 weeks after Radiotherapy start ]blood volume
- Analysis of Tumor tissue and normal tissue [ Time Frame: 3 month after Radiotherapy start ]blood volume
- Analysis of Tumor tissue and normal tissue [ Time Frame: previouse to Radiotherapy start ]amount of collagen
- Analysis of Tumor tissue and normal tissue [ Time Frame: 3 weeks after Radiotherapy start ]amount of collagen
- Analysis of Tumor tissue and normal tissue [ Time Frame: 3 month after Radiotherapy start ]amount of collagen
- multimodal information about tissue morphology [ Time Frame: previouse to Radiotherapy start ]Registration of photoaccustic and MRI/CT Imaging
- multimodal information about tissue function [ Time Frame: 3 weeks after Radiotherapy start ]Registration of photoaccustic and MRI/CT Imaging
- multimodal information about tissue function [ Time Frame: 3 month after Radiotherapy start ]Registration of photoaccustic and MRI/CT Imaging

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437030
Contact: Thomas Held, MD | 06221 56 ext 8201 | thomas.held@med.uni-heidelberg.de | |
Contact: Adriane Hommertgen, Dr. rer. nat. | 06221 56 ext 8201 |
Germany | |
University Hopsital Heidelberg | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: Jürgen Debus, MD PhD +49 6221 56 ext 34093 juergen.debus@med.uni-heidelberg.de |
Principal Investigator: | Sebastian Adeberg, PD | University Hospital Heidelberg |
Responsible Party: | Juergen Debus, Head of Department, University Hospital Heidelberg |
ClinicalTrials.gov Identifier: | NCT04437030 |
Other Study ID Numbers: |
MSOT HNC |
First Posted: | June 18, 2020 Key Record Dates |
Last Update Posted: | April 28, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |