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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Radiotherapy
• Intervention / Treatment: Device: OCT; Device: Dermatoscope; Genetic: 3-Colour FISH

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).

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Elisabeth Silberberger, MSC; Phone Number: 6484 +43 (732) 7677; Email: elisabeth.silberberger@ordensklinikum.at
• Study Contact Backup: Name: Hans Geinitz, Prim. Univ.-Prof. Dr.; Phone Number: 6938 +43 (732) 7677; Email: hans.geinitz@ordensklinikum.at

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Recruiting
      • Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern
      • Contact: Elisabeth Silberberger, MSC; Phone Number: 6484 +43 (732) 7677; Email: elisabeth.silberberger@ordensklinikum.at
      • Contact: Hans Geinitz, Prim. Univ.-Prof. Dr.; Phone Number: 6938 +43 (732) 7677; Email: hans.geinitz@ordensklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Head and Neck Cancer Patients; Patients with adjuvant or definitve radiotherapy or radio-chemotherapy for head and neck cancer

Device: OCT; 3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck; Other Names: Lumedica OQlabscope 2.0; Device: Dermatoscope; 2x2 pictures taken with a dermatoscope; Other Names: Heine iC1 Set/6; Genetic: 3-Colour FISH; Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual; 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

Collaborators and Investigators

• Sponsor: Krankenhaus Barmherzige Schwestern Linz
• Collaborators: Verein zur Forschungsförderung der Krebshilfe OÖ; RECENDT GmbH; Johannes Kepler Universität Linz, Abteilung FLLL; Universitätsklinikum Erlangen; Andreas Fahl Medizintechnik-Vertrieb GmbH
• Investigators: Principal Investigator: Hans Geinitz, Prim. Univ.-Prof. Dr., Ordensklinikum Linz GmbH Barmherzige Schwestern (Dept. Radiooncology)

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Anticipated): December 8, 2026
• Study Completion (Anticipated): December 8, 2026

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: OCT; Quality of Life; Optical coherence tomography; radiotherapy; radiation therapy; Head and neck cancer; Radiochemotherapy; skin toxicity; FISH; EORTC QLQ C30; radiation sensitivity; EORTC H&N 43
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: EKS 39/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No