Head and Neck CancerROOCTNCT04610645
Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer
An observational study of Head and Neck Cancer and Radiotherapy, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Head and Neck Cancer, Radiotherapy
- What is being tested?
- OCT and Dermatoscope
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jun 2020to 8 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutively treated patients with head and neck cancer at the department of radiation therapy Ordensklinikum Linz Barmherzige Schwestern
Who may be able to join
- Patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy
Who cannot join
- reduced mental capacity
- treatment with C225 Cetuximab
- bearded patients
- overt skin disease
- vast tattoos in the neck region
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Upper Austria, 4010
About this study
Official title: Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients
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.
Read the 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).
- Conditions
- Head and Neck Cancer, Radiotherapy
- Being tested
- OCT, Dermatoscope
- Keywords
- Optical coherence tomography, OCT, Head and neck cancer, radiotherapy, radiation therapy, skin toxicity, radiation sensitivity, EORTC H&N 43, Radiochemotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
Also called Lumedica OQlabscope 2.0
3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck
DermatoscopeDevice
Also called Heine iC1 Set/6
2x2 pictures taken with a dermatoscope
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Cancer Patients | Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer Receives: Device: OCT; Device: Dermatoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
early radiation induced skin structure changes detected in OCT
any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)
Measured: First week of radiation therapy
Secondary outcomes (6)
detection of any skin strucure changes with OCT during the course of RT
any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)
Measured: weeks 1 - 6 of radiation therapy
Correlation of OCT changes with clinical appearent acute side effetcs
Correlation of OCT changes with CTC radiation toxicity
Measured: weeks 1 - 6 of radiation therapy
Correlation of OCT changes with clinical appearent late side effetcs
Correlation of OCT changes with CTC radiation toxicity
Measured: 1 year post-RT
Correlation of OCT changes with radiation sensitivity
Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH)
Measured: OCT: weeks 1-6 of radiation therapy; FISH: pre-RT
Correlation of OCT changes with dermatoscopic skin appearance
Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy
Measured: weeks 1-6 of RT
Correlation of quality of live with OCT and radiation sensitivity
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
Measured: weeks 1-6 of RT, 6 weeks and 1 year post-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start8 Jun 2020
- Primary completion8 Dec 2024
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Verein zur Forschungsförderung der Krebshilfe OÖ, RECENDT GmbH, Johannes Kepler Universität Linz, Abteilung FLLL, University of Erlangen-Nürnberg, Andreas Fahl Medizintechnik-Vertrieb GmbH
- Responsible party
- Principal investigator, Hans Geinitz, Krankenhaus Barmherzige Schwestern Linz
- Investigators
- Hans Geinitz, Prim. Univ.-Prof. Dr., Principal investigator, Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610645
- Sponsor's protocol ID
- EKS 39/18
- Acronym
- ROOCT
- Status last verified
- Jan 2026
- First submitted
- 29 Oct 2020
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40548163
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT04610645
- Acronym / sponsor ID
- ROOCT / EKS 39/18
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Collaborators
- Verein zur Forschungsförderung der Krebshilfe OÖ, RECENDT GmbH, Johannes Kepler Universität Linz, Abteilung FLLL, University of Erlangen-Nürnberg, Andreas Fahl Medizintechnik-Vertrieb GmbH
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Cancer Patients | – | Device: OCT, Device: DermatoscopePatients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutively treated patients with head and neck cancer at the department of radiation therapy Ordensklinikum Linz Barmherzige Schwestern
Key inclusion criteria (1 listed)
- Patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy
Key exclusion criteria (5 listed)
- reduced mental capacity
- treatment with C225 Cetuximab
- bearded patients
- overt skin disease
- vast tattoos in the neck region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCTAlso: Lumedica OQlabscope 2.03x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck | Device | Head and Neck Cancer Patients |
| DermatoscopeAlso: Heine iC1 Set/62x2 pictures taken with a dermatoscope | Device | Head and Neck Cancer Patients |
Primary outcome
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)
6 secondary outcomes
detection of any skin strucure changes with OCT during the course of RT
Time frame: weeks 1 - 6 of radiation therapy
Correlation of OCT changes with clinical appearent acute side effetcs
Time frame: weeks 1 - 6 of radiation therapy
Correlation of OCT changes with clinical appearent late side effetcs
Time frame: 1 year post-RT
Correlation of OCT changes with radiation sensitivity
Time frame: OCT: weeks 1-6 of radiation therapy; FISH: pre-RT
Correlation of OCT changes with dermatoscopic skin appearance
Time frame: weeks 1-6 of RT
Correlation of quality of live with OCT and radiation sensitivity
Time frame: weeks 1-6 of RT, 6 weeks and 1 year post-RT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Results publication: PubMed 40548163Heise 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Geinitz, Prim. Univ.-Prof. Dr. principal investigator
Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Radiotherapy, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early radiation induced skin structure changes detected in OCT (time frame: First week of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.