Clinical trial · Observational
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
NCT04610645CI-TRIAL-00104412ROOCTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dermatoscope | Device | — | UNRESOLVED |
| OCT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Head and Neck Cancer Patients
- description
- Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer
- interventionNames
- Device: OCT
- Device: Dermatoscope
Primary outcomes (1)
- measure
- early radiation induced skin structure changes detected in OCT
- timeFrame
- First week of radiation therapy
- description
- any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)
Secondary outcomes (6)
- measure
- detection of any skin strucure changes with OCT during the course of RT
- timeFrame
- weeks 1 - 6 of radiation therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTHeise 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 40548163