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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04437030

Studienbeginn:
Juli 2020

Letztes Update:
28.04.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Studienleiter

Sebastian Adeberg, PD
Principal Investigator
University Hospital Heidelberg

Kontakt

Studienlocations
(1 von 1)

University Hopsital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jürgen Debus, MD PhD
Phone: +49 6221 56
Phone (ext.): 34093
E-Mail: juergen.debus@med.uni-heidelberg.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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

Studien-Arme

  • Active Comparator: Patient
    Patient with Head and neck cancer
  • Other: Healthy subjects
    Healty subjects with not history of Tumor disease in the Head and neck region

Geprüfte Regime

  • MSOT Acuity Echo device:
    The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings.

Quelle: ClinicalTrials.gov


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