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

NCT04437030 | Completed

• 1 other identifier: MSOT HNC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (12)

• Analysis of Tumor tissue and normal tissue

  previouse to Radiotherapy start

• Analysis of Tumor tissue and normal tissue

  3 weeks after Radiotherapy start

• Analysis of Tumor tissue and normal tissue

  3 month after Radiotherapy start

• Analysis of Tumor tissue and normal tissue

  previouse to Radiotherapy start

• Analysis of Tumor tissue and normal tissue

  3 weeks after Radiotherapy start

Study Arms (2)

Patient

ACTIVE COMPARATOR

Patient with Head and neck cancer

Device: MSOT Acuity Echo device

Healthy subjects

OTHER

Healty subjects with not history of Tumor disease in the Head and neck region

Device: MSOT Acuity Echo device

Interventions

MSOT Acuity Echo device DEVICE

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

Healthy subjects; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• \. Age ≥ 18 years.
• Requirement 3 does not apply to the control group of healthy subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hopsital Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Sebastian Adeberg, PD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 18, 2020
• Study Start: July 9, 2020
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)