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

Sponsor
Krankenhaus Barmherzige Schwestern Linz (Other)
Overall Status
Recruiting
CT.gov ID
NCT04610645
Collaborator
Verein zur Forschungsförderung der Krebshilfe OÖ (Other), RECENDT GmbH (Other), Johannes Kepler Universität Linz, Abteilung FLLL (Other), Universitätsklinikum Erlangen (Other), Andreas Fahl Medizintechnik-Vertrieb GmbH (Other)
50
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Live Laser Microscopic Evaluation (OCT) of Radiation Induced Preclinical Alterations of the Skin in Head and Neck Cancer Patients
Actual Study Start Date :
Jun 8, 2020
Anticipated Primary Completion Date :
Dec 8, 2026
Anticipated Study Completion Date :
Dec 8, 2026

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. early radiation induced skin structure changes detected in OCT [First week of radiation therapy]

      any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

    Secondary Outcome Measures

    1. detection of any skin strucure changes with OCT during the course of RT [weeks 1 - 6 of radiation therapy]

      any reproducible difference in skin OCT appearance as compared with baseline (pre-RT)

    2. Correlation of OCT changes with clinical appearent acute side effetcs [weeks 1 - 6 of radiation therapy]

      Correlation of OCT changes with CTC radiation toxicity

    3. Correlation of OCT changes with clinical appearent late side effetcs [1 year post-RT]

      Correlation of OCT changes with CTC radiation toxicity

    4. Correlation of OCT changes with radiation sensitivity [OCT: weeks 1-6 of radiation therapy; FISH: pre-RT]

      Correlation of OCT with chromosome-breaks per metaphasis in in-vitro irradiated blood lymphocytes (FISH)

    5. Correlation of OCT changes with dermatoscopic skin appearance [weeks 1-6 of RT]

      Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy

    6. Correlation of quality of live with OCT and radiation sensitivity [weeks 1-6 of RT, 6 weeks and 1 year post-RT]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Radiooncology, Ordensklinikum Linz GmbH Barmherzige Schwestern Linz Upper Austria Austria 4010

    Sponsors and Collaborators

    • Krankenhaus Barmherzige Schwestern Linz
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hans Geinitz, Prim. Univ.-Prof. Dr., Krankenhaus Barmherzige Schwestern Linz
    ClinicalTrials.gov Identifier:
    NCT04610645
    Other Study ID Numbers:
    • EKS 39/18
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hans Geinitz, Prim. Univ.-Prof. Dr., Krankenhaus Barmherzige Schwestern Linz
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022