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Completed

NCT Number: NCT04610645

Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer

The purpose of this study is to determine whether any eventual skin damage caused by radiation therapy can be detected and monitored at a subclinical level via optical coherence tomography (OCT). Another key question is whether subclinical OCT detected skin damage correlates with acute and late clinical toxicity.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiotherapy

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria, 4010, Austria

About this study

Head and neck cancer patients that meet the eligibility criteria and singned the informed consent will undergo OCT-measurements before, during and after the course of radiation therapy. At the same time-points the skin areas are evaluated with dermatoscopy and patients are asked to self-assess their quality of life (EORTC QLQ C30 and respective head and neck module H&N 43).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy

Exclusion criteria

  • reduced mental capacity
  • treatment with C225 Cetuximab
  • bearded patients
  • overt skin disease
  • vast tattoos in the neck region

Treatment and study plan

OCT

Device

3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck

Other names: Lumedica OQlabscope 2.0

Dermatoscope

Device

2x2 pictures taken with a dermatoscope

Other names: Heine iC1 Set/6

Primary outcomes

  1. early radiation induced skin structure changes detected in OCT

    Time frame: First week of radiation therapy

    any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

Secondary outcomes

  1. detection of any skin strucure changes with OCT during the course of RT

    Time frame: weeks 1 - 6 of radiation therapy

    any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

  2. Correlation of OCT changes with clinical appearent acute side effetcs

    Time frame: weeks 1 - 6 of radiation therapy

    Correlation of OCT changes with CTC radiation toxicity

  3. Correlation of OCT changes with clinical appearent late side effetcs

    Time frame: 1 year post-RT

    Correlation of OCT changes with CTC radiation toxicity

  4. Correlation of OCT changes with radiation sensitivity

    Time frame: OCT: weeks 1-6 of radiation therapy; FISH: pre-RT

    Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH)

  5. Correlation of OCT changes with dermatoscopic skin appearance

    Time frame: weeks 1-6 of RT

    Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy

  6. Correlation of quality of live with OCT and radiation sensitivity

    Time frame: weeks 1-6 of RT, 6 weeks and 1 year post-RT

    Correlation of quality of live as measured with the EORT QLC C30 and Head and neck module H&N 43 with OCT and radiation sensitivity

Sponsors and collaborators

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Other

Collaborators

  • Andreas Fahl Medizintechnik-Vertrieb GmbH
  • Johannes Kepler Universität Linz, Abteilung FLLL
  • RECENDT GmbH
  • Universitätsklinikum Erlangen
  • Verein zur Forschungsförderung der Krebshilfe OÖ

Registry information

Official study title

Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients

Acronym: ROOCT

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Oct 30, 2020
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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