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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 9, 2020
First Posted Date  ICMJE June 18, 2020
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE July 9, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
Official Title  ICMJE Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Device: MSOT Acuity Echo device
The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings.
Study Arms  ICMJE
  • Active Comparator: Patient
    Patient with Head and neck cancer
    Intervention: Device: MSOT Acuity Echo device
  • Healthy subjects
    Healty subjects with not history of Tumor disease in the Head and neck region
    Intervention: Device: MSOT Acuity Echo device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Thomas Held, MD 06221 56 ext 8201 thomas.held@med.uni-heidelberg.de
Contact: Adriane Hommertgen, Dr. rer. nat. 06221 56 ext 8201
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04437030
Other Study ID Numbers  ICMJE MSOT HNC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Juergen Debus, University Hospital Heidelberg
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital Heidelberg
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sebastian Adeberg, PD University Hospital Heidelberg
PRS Account University Hospital Heidelberg
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP