Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:
- Sponsor
- University of Kragujevac
- Study ID
- NCT07690631
- Status
- Not Yet Recruiting
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Conditions
- Head and Neck Cancer
- Microplastic Exposure
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
MICRORAD is a pioneering 48-month translational research project that investigates the potential health and environmental impacts of micro- and nanoplastics (MNPs) released from medical devices when exposed to ionizing radiation. In radiation oncology, thermoplastic masks (TPMs) are standard immobilization tools, particularly for head and neck (HN) cancer patients. Globally, approximately 2.65 million TPMs are used annually in the radiotherapy of HN cancer patients and with an additional 8 to 10 million for other tumor types. TPMs are repeatedly subjected to high-energy X-rays and frequent handling, raising concerns about polymer degradation and the release of MNPs, which may interfere with treatment efficacy or contribute to radiation toxicity. MICRORAD is the first translational study to explore this phenomenon by integrating clinical oncology, materials science, radiobiology, and data science. The project will analyze radiation-induced changes in TPMs, quantify MNP release, and assess their biological effects through in vitro, in vivo, and clinical studies. Using advanced detection techniques, the project will characterize MNPs and trace their biodistribution, while a clinical pilot will correlate MNP exposure with treatment outcomes. Data integration, biostatistics, and AI-based modeling will support the translation of findings into clinical guidelines, policy briefs, and public communication. A multidisciplinary team will collaborate to ensure real-world impact. By bridging oncology and environmental health, MICRORAD aims to establish eco-oncology as a new field, contributing to patient safety and sustainable innovation.
Key Dates
- First listed
- Jul 8, 2026
- Start date
- Sep 30, 2026
- Status verified
- Feb 2026
- Primary completion
- Oct 31, 2029
- Completion
- Oct 31, 2030
Study Design
- Enrollment
- 500 participants (estimated)
Primary Outcome Measure
MNPs effect on head and neck cancer patiens [ Time Frame: From enrollment to the 6 month FU treatment ]
Central Contacts
- Marija N Zivkovic Radojevic, Assistant Professor, MD PhD+381658384450
- Neda Milosavljevic, Assistant Professor, MD PhD+381638429691
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