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

Study Overview
=================
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). Before the onset of radiation therapy radiation sensitivity analysis will be performed with in-vitro irradion of peripheral blood lymphocytes (FISH).

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

Conditions
-----------------
Head and Neck Cancer, Radiotherapy

Intervention / Treatment
-----------------
* Device: OCT
* Device: Dermatoscope
* Genetic: 3-Colour FISH


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Head and Neck Cancer Patients<br>Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer | Device: OCT<br>* 3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck<br>* Other names: Lumedica OQlabscope 2.0;Device: Dermatoscope<br>* 2x2 pictures taken with a dermatoscope<br>* Other names: Heine iC1 Set/6;Genetic: 3-Colour FISH<br>* Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual<br>* Other names: Fluorescent In Situ Hybridisation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | weeks 1 - 6 of radiation therapy | 
| Correlation of OCT changes with clinical appearent acute side effetcs | Correlation of OCT changes with CTC radiation toxicity | weeks 1 - 6 of radiation therapy | 
| Correlation of OCT changes with clinical appearent late side effetcs | Correlation of OCT changes with CTC radiation toxicity | 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) | 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 | 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 | weeks 1-6 of RT, 6 weeks and 1 year post-RT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCT, Optical coherence tomography, Head and neck cancer, radiotherapy, radiation therapy, skin toxicity, radiation sensitivity, FISH, Quality of Life, EORTC QLQ C30, EORTC H&N 43, Radiochemotherapy