Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: MSOT Acuity Echo device

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • University Hopsital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Willingness and ability to participate
2. sufficient knowledge of German to understand the patient / subject information and the declaration of consent,
3. tumor disease to be treated by radiotherapy in the neck and neck area,
4. Completed wound healing after operative interventions in the head and neck area,
5. The patient's consent and written consent,
6. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient; Patient with Head and neck cancer	Device: MSOT Acuity Echo device; The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation	Measurement of Oxygen Saturation in the tumor tissue	previouse to Radiotherapy start
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation	Measurement of Oxygen Saturation in the tumor tissue	3 weeks after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation	Measurement of Oxygen Saturation in the tumor tissue	3 month after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: blood volume	blood volume	previouse to Radiotherapy start
diagnostic feasibility of photoacoustic imaging: blood volume	blood volume	3 weeks after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: blood volume	blood volume	3 month after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: blood volume	amount of collagen in the tumor tissue	previouse to Radiotherapy start
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue	amount of collagen in the tumor tissue	3 weeks after Radiotherapy start
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue	amount of collagen in the tumor tissue	3 month after Radiotherapy start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Tumor tissue and normal tissue	Differences of Oxygen saturation	previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue	Differences of Oxygen saturation	3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue	Differences of Oxygen saturation	3 month after Radiotherapy start
Analysis of Tumor tissue and normal tissue	blood volume	previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue	blood volume	3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue	blood volume	3 month after Radiotherapy start
Analysis of Tumor tissue and normal tissue	amount of collagen	previouse to Radiotherapy start
Analysis of Tumor tissue and normal tissue	amount of collagen	3 weeks after Radiotherapy start
Analysis of Tumor tissue and normal tissue	amount of collagen	3 month after Radiotherapy start
multimodal information about tissue morphology	Registration of photoaccustic and MRI/CT Imaging	previouse to Radiotherapy start
multimodal information about tissue function	Registration of photoaccustic and MRI/CT Imaging	3 weeks after Radiotherapy start
multimodal information about tissue function	Registration of photoaccustic and MRI/CT Imaging	3 month after Radiotherapy start

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Sebastian Adeberg, PD, University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: MSOT HNC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No