NCT04610645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2025

Completed
Last Updated

March 3, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

October 29, 2020

Last Update Submit

February 28, 2026

Conditions

RadiotherapyHead and Neck Cancer

Keywords

Optical coherence tomographyOCTHead and neck cancerradiotherapyradiation therapyskin toxicityradiation sensitivityEORTC H&N 43Radiochemotherapy

Outcome Measures

Primary Outcomes (1)

  • early radiation induced skin structure changes detected in OCT

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

    First week of radiation therapy

Secondary Outcomes (6)

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

    weeks 1 - 6 of radiation therapy

  • Correlation of OCT changes with clinical appearent acute side effetcs

    weeks 1 - 6 of radiation therapy

  • Correlation of OCT changes with clinical appearent late side effetcs

    1 year post-RT

  • Correlation of OCT changes with radiation sensitivity

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

  • Correlation of OCT changes with dermatoscopic skin appearance

    weeks 1-6 of RT

  • +1 more secondary outcomes

Study Arms (1)

Head and Neck Cancer Patients

Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer

Device: OCTDevice: Dermatoscope

Interventions

OCTDEVICE

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

Also known as: Lumedica OQlabscope 2.0
Head and Neck Cancer Patients
DermatoscopeDEVICE

2x2 pictures taken with a dermatoscope

Also known as: Heine iC1 Set/6
Head and Neck Cancer Patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutively treated patients with head and neck cancer at the department of radiation therapy Ordensklinikum Linz Barmherzige Schwestern

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria, 4010, Austria

Location

Related Publications (1)

  • Heise B, Schlagnitweit P, Pollak R, Felbermayer K, Silberberger E, Kocik L, Trinkl L, Weinzinger D, Anderlik P, Springer A, Geroldinger-Simic M, Gruber G, Hartl M, Geinitz H. Monitoring of Early Skin Reactions by Optical Coherence Tomography and Dermatoscopy in Patients Receiving Radiation Therapy for Head and Neck Cancer. Adv Radiat Oncol. 2025 Jun 10;10(7):101793. doi: 10.1016/j.adro.2025.101793. eCollection 2025 Jul.

    PMID: 40548163RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Hans Geinitz, Prim. Univ.-Prof. Dr.

    Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prim. Univ.-Prof. Dr.

Study Record Dates

First Submitted

October 29, 2020

First Posted

October 30, 2020

Study Start

June 8, 2020

Primary Completion

December 8, 2024

Study Completion

April 8, 2025

Last Updated

March 3, 2026

Record last verified: 2026-01

Locations

AU(1)