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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
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Device: MSOT Acuity Echo device Not Applicable

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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. diagnostic feasibility of photoacoustic imaging: Oxygen Saturation [ Time Frame: previouse to Radiotherapy start ]
    Measurement of Oxygen Saturation in the tumor tissue

  2. diagnostic feasibility of photoacoustic imaging: Oxygen Saturation [ Time Frame: 3 weeks after Radiotherapy start ]
    Measurement of Oxygen Saturation in the tumor tissue

  3. diagnostic feasibility of photoacoustic imaging: Oxygen Saturation [ Time Frame: 3 month after Radiotherapy start ]
    Measurement of Oxygen Saturation in the tumor tissue

  4. diagnostic feasibility of photoacoustic imaging: blood volume [ Time Frame: previouse to Radiotherapy start ]
    blood volume

  5. diagnostic feasibility of photoacoustic imaging: blood volume [ Time Frame: 3 weeks after Radiotherapy start ]
    blood volume

  6. diagnostic feasibility of photoacoustic imaging: blood volume [ Time Frame: 3 month after Radiotherapy start ]
    blood volume

  7. diagnostic feasibility of photoacoustic imaging: blood volume [ Time Frame: previouse to Radiotherapy start ]
    amount of collagen in the tumor tissue

  8. 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

  9. 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


Secondary Outcome Measures :
  1. Analysis of Tumor tissue and normal tissue [ Time Frame: previouse to Radiotherapy start ]
    Differences of Oxygen saturation

  2. Analysis of Tumor tissue and normal tissue [ Time Frame: 3 weeks after Radiotherapy start ]
    Differences of Oxygen saturation

  3. Analysis of Tumor tissue and normal tissue [ Time Frame: 3 month after Radiotherapy start ]
    Differences of Oxygen saturation

  4. Analysis of Tumor tissue and normal tissue [ Time Frame: previouse to Radiotherapy start ]
    blood volume

  5. Analysis of Tumor tissue and normal tissue [ Time Frame: 3 weeks after Radiotherapy start ]
    blood volume

  6. Analysis of Tumor tissue and normal tissue [ Time Frame: 3 month after Radiotherapy start ]
    blood volume

  7. Analysis of Tumor tissue and normal tissue [ Time Frame: previouse to Radiotherapy start ]
    amount of collagen

  8. Analysis of Tumor tissue and normal tissue [ Time Frame: 3 weeks after Radiotherapy start ]
    amount of collagen

  9. Analysis of Tumor tissue and normal tissue [ Time Frame: 3 month after Radiotherapy start ]
    amount of collagen

  10. multimodal information about tissue morphology [ Time Frame: previouse to Radiotherapy start ]
    Registration of photoaccustic and MRI/CT Imaging

  11. multimodal information about tissue function [ Time Frame: 3 weeks after Radiotherapy start ]
    Registration of photoaccustic and MRI/CT Imaging

  12. multimodal information about tissue function [ Time Frame: 3 month after Radiotherapy start ]
    Registration of photoaccustic and MRI/CT Imaging


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Thomas Held, MD 06221 56 ext 8201 thomas.held@med.uni-heidelberg.de
Contact: Adriane Hommertgen, Dr. rer. nat. 06221 56 ext 8201

Locations
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Germany
University Hopsital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Jürgen Debus, MD PhD    +49 6221 56 ext 34093    juergen.debus@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
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Principal Investigator: Sebastian Adeberg, PD University Hospital Heidelberg
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms