ROOCT: Optical Coherence Tomography in Patients With Radiotherapy for Head and Neck Cancer
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
Device: Dermatoscope
2x2 pictures taken with a dermatoscope
Other Names:
Genetic: 3-Colour FISH
Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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)
- Correlation of OCT changes with clinical appearent acute side effetcs [weeks 1 - 6 of radiation therapy]
Correlation of OCT changes with CTC radiation toxicity
- Correlation of OCT changes with clinical appearent late side effetcs [1 year post-RT]
Correlation of OCT changes with CTC radiation toxicity
- 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)
- Correlation of OCT changes with dermatoscopic skin appearance [weeks 1-6 of RT]
Correlation of OCT changes with standardised evaluated skin appearence via dermatoscopy
- 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
Inclusion Criteria:
- Patients with cancer located at: nasopharynx, oropharynx, hypopharynx, larynx, oral cavity and definitive or adjuvant radiation- or radio-chemotherapy
Exclusion Criteria:
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reduced mental capacity
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treatment with C225 Cetuximab
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bearded patients
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overt skin disease
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vast tattoos in the neck region
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- EKS 39/18