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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04610645

Acronym

ROOCT

Enrollment

Registered

2020-10-30

Start date

2020-06-08

Completion date

2025-04-08

Last updated

2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Radiotherapy

Keywords

Optical coherence tomography, OCT, Head and neck cancer, radiotherapy, radiation therapy, skin toxicity, radiation sensitivity, EORTC H&N 43, Radiochemotherapy

Brief summary

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.

Detailed description

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).

Interventions

DEVICEOCT

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

DEVICEDermatoscope

2x2 pictures taken with a dermatoscope

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
early radiation induced skin structure changes detected in OCT	First week of radiation therapy	any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

Secondary

Measure	Time frame	Description
detection of any skin strucure changes with OCT during the course of RT	weeks 1 - 6 of radiation therapy	any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)
Correlation of OCT changes with clinical appearent acute side effetcs	weeks 1 - 6 of radiation therapy	Correlation of OCT changes with CTC radiation toxicity
Correlation of OCT changes with clinical appearent late side effetcs	1 year post-RT	Correlation of OCT changes with CTC radiation toxicity
Correlation of OCT changes with radiation sensitivity	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)
Correlation of OCT changes with dermatoscopic skin appearance	weeks 1-6 of RT	Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy
Correlation of quality of live with OCT and radiation sensitivity	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

Countries

Austria

Contacts

PRINCIPAL_INVESTIGATORHans Geinitz, Prim. Univ.-Prof. Dr.

Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026