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

Head and Neck Cancer Clinical Trial

— ROOCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610645
• Other study ID #: EKS 39/18
• Status: Recruiting
• Start date: June 8, 2020
• Est. completion date: December 8, 2026

Study information

• Verified date: March 2022
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: Elisabeth Silberberger, MSc
• Phone: +43 (732) 7677
• Email: elisabeth.silberberger[@]ordensklinikum.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 8, 2026
• Est. primary completion date: December 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiotherapy

Intervention

Device:
• OCT
3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck
• Dermatoscope
2x2 pictures taken with a dermatoscope

Genetic:
• 3-Colour FISH
Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual

Locations

Country	Name	City	State
Austria	Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern	Linz	Upper Austria

Sponsors (6)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz	Andreas Fahl Medizintechnik-Vertrieb GmbH, Johannes Kepler Universität Linz, Abteilung FLLL, RECENDT GmbH, Universitätsklinikum Erlangen, Verein zur Forschungsförderung der Krebshilfe OÖ

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlation of OCT changes with clinical appearent acute side effetcs	Correlation of OCT changes with CTC radiation toxicity	weeks 1 - 6 of radiation therapy
Secondary	Correlation of OCT changes with clinical appearent late side effetcs	Correlation of OCT changes with CTC radiation toxicity	1 year post-RT
Secondary	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
Secondary	Correlation of OCT changes with dermatoscopic skin appearance	Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy	weeks 1-6 of RT
Secondary	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