Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MSOT Acuity Echo device
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer
Eligibility Criteria
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
Sites / Locations
- University Hopsital HeidelbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Patient
Healthy subjects
Arm Description
Patient with Head and neck cancer
Healty subjects with not history of Tumor disease in the Head and neck region
Outcomes
Primary Outcome Measures
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Measurement of Oxygen Saturation in the tumor tissue
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Measurement of Oxygen Saturation in the tumor tissue
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Measurement of Oxygen Saturation in the tumor tissue
diagnostic feasibility of photoacoustic imaging: blood volume
blood volume
diagnostic feasibility of photoacoustic imaging: blood volume
blood volume
diagnostic feasibility of photoacoustic imaging: blood volume
blood volume
diagnostic feasibility of photoacoustic imaging: blood volume
amount of collagen in the tumor tissue
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
amount of collagen in the tumor tissue
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
amount of collagen in the tumor tissue
Secondary Outcome Measures
Analysis of Tumor tissue and normal tissue
Differences of Oxygen saturation
Analysis of Tumor tissue and normal tissue
Differences of Oxygen saturation
Analysis of Tumor tissue and normal tissue
Differences of Oxygen saturation
Analysis of Tumor tissue and normal tissue
blood volume
Analysis of Tumor tissue and normal tissue
blood volume
Analysis of Tumor tissue and normal tissue
blood volume
Analysis of Tumor tissue and normal tissue
amount of collagen
Analysis of Tumor tissue and normal tissue
amount of collagen
Analysis of Tumor tissue and normal tissue
amount of collagen
multimodal information about tissue morphology
Registration of photoaccustic and MRI/CT Imaging
multimodal information about tissue function
Registration of photoaccustic and MRI/CT Imaging
multimodal information about tissue function
Registration of photoaccustic and MRI/CT Imaging
Full Information
NCT ID
NCT04437030
First Posted
June 9, 2020
Last Updated
April 27, 2021
Sponsor
University Hospital Heidelberg
1. Study Identification
Unique Protocol Identification Number
NCT04437030
Brief Title
Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
Official Title
Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient
Arm Type
Active Comparator
Arm Description
Patient with Head and neck cancer
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
Healty subjects with not history of Tumor disease in the Head and neck region
Intervention Type
Device
Intervention Name(s)
MSOT Acuity Echo device
Intervention Description
The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings.
Primary Outcome Measure Information:
Title
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Description
Measurement of Oxygen Saturation in the tumor tissue
Time Frame
previouse to Radiotherapy start
Title
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Description
Measurement of Oxygen Saturation in the tumor tissue
Time Frame
3 weeks after Radiotherapy start
Title
diagnostic feasibility of photoacoustic imaging: Oxygen Saturation
Description
Measurement of Oxygen Saturation in the tumor tissue
Time Frame
3 month after Radiotherapy start
Title
diagnostic feasibility of photoacoustic imaging: blood volume
Description
blood volume
Time Frame
previouse to Radiotherapy start
Title
diagnostic feasibility of photoacoustic imaging: blood volume
Description
blood volume
Time Frame
3 weeks after Radiotherapy start
Title
diagnostic feasibility of photoacoustic imaging: blood volume
Description
blood volume
Time Frame
3 month after Radiotherapy start
Title
diagnostic feasibility of photoacoustic imaging: blood volume
Description
amount of collagen in the tumor tissue
Time Frame
previouse to Radiotherapy start
Title
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
Description
amount of collagen in the tumor tissue
Time Frame
3 weeks after Radiotherapy start
Title
diagnostic feasibility of photoacoustic imaging: amount of collagen in the tumor tissue
Description
amount of collagen in the tumor tissue
Time Frame
3 month after Radiotherapy start
Secondary Outcome Measure Information:
Title
Analysis of Tumor tissue and normal tissue
Description
Differences of Oxygen saturation
Time Frame
previouse to Radiotherapy start
Title
Analysis of Tumor tissue and normal tissue
Description
Differences of Oxygen saturation
Time Frame
3 weeks after Radiotherapy start
Title
Analysis of Tumor tissue and normal tissue
Description
Differences of Oxygen saturation
Time Frame
3 month after Radiotherapy start
Title
Analysis of Tumor tissue and normal tissue
Description
blood volume
Time Frame
previouse to Radiotherapy start
Title
Analysis of Tumor tissue and normal tissue
Description
blood volume
Time Frame
3 weeks after Radiotherapy start
Title
Analysis of Tumor tissue and normal tissue
Description
blood volume
Time Frame
3 month after Radiotherapy start
Title
Analysis of Tumor tissue and normal tissue
Description
amount of collagen
Time Frame
previouse to Radiotherapy start
Title
Analysis of Tumor tissue and normal tissue
Description
amount of collagen
Time Frame
3 weeks after Radiotherapy start
Title
Analysis of Tumor tissue and normal tissue
Description
amount of collagen
Time Frame
3 month after Radiotherapy start
Title
multimodal information about tissue morphology
Description
Registration of photoaccustic and MRI/CT Imaging
Time Frame
previouse to Radiotherapy start
Title
multimodal information about tissue function
Description
Registration of photoaccustic and MRI/CT Imaging
Time Frame
3 weeks after Radiotherapy start
Title
multimodal information about tissue function
Description
Registration of photoaccustic and MRI/CT Imaging
Time Frame
3 month after Radiotherapy start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Held, MD
Phone
06221 56
Ext
8201
Email
thomas.held@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Adriane Hommertgen, Dr. rer. nat.
Phone
06221 56
Ext
8201
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Adeberg, PD
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hopsital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Debus, MD PhD
Phone
+49 6221 56
Ext
34093
Email
juergen.debus@med.uni-heidelberg.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multiparametric Photoacoustic Imaging in the Course of Radiation Therapy of Malignant Head and Neck Tumors
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