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NCT06215612 Clinical Trial

ctDNA and MRI Parameters in Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:
ctDNA and MR Imaging Parameters as Possible Biomarkers in Primary Radiochemotherapy of Head and Neck Squamous Cell Carcinomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06215612
Other study ID # 1452/2023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date February 2030

Study information
Verified date January 2024
Source Medical University of Vienna
Contact Franziska Eckert, M.D.
Phone +43-1-40400-26920
Email franziska.eckert@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients undergoing primary radiochhemotherapy for locally advanced head and neck squamous cell carcinomas are included in this study. In addition to standard of care treatment patients will undergo addiational blood draws and MR imaging studies. Circulating cell free tumor DNA will be analysed in the blood samples. BIological data, imaging data and clinical data (such as patient and tumor characteristics, oncologic outcome, side effects) will be analysed in a biomathematical modelling approach.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date February 2030
Est. primary completion date February 2027
Accepts healthy volunteers No
Gender All
Age group 19 Years to 100 Years
Eligibility Inclusion Criteria: - Squamous cell carcinoma head and neck - Planned primary platinum based radiochemotherapy - ECOG 0-2 Exclusion Criteria: - Palliative therapy intent - Not MR eligible

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood draw, MRI
Blood draw, MRI

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Franziska Eckert

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of patients with 50% decrease in ctDNA 7 weeks after start of radiotherapy
Secondary Completion of all planned MR imagings and blood tests through study completion, an average of 7 weeks
Secondary Decrease of tumor volume 7 weeks after start of radiotherapy
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