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NCT Number: NCT07690631

Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any stage head and neck cancer patients
  • Eastern Cooperative Oncology Group performance status 0-2
  • Undergoing radiotherapy with/without cisplatin chemopotentiation
  • Signed informed consent

Exclusion criteria

  • Pregnancy or lactation
  • Mental illness
  • Prior or concurrent malignancies
  • Immunotherapy or immunosuppressive therapy
  • Immune diseases

Treatment and study plan

Primary outcomes

  1. MNPs effect on head and neck cancer patiens

    Time frame: From enrollment to the 6 month FU treatment

    To characterize MNPs and trace their biodistribution and to correlate MNP exposure with treatment outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Marija N Zivkovic Radojevic, Assistant Professor, MD PhD

CONTACT

[email protected]

+381658384450

Neda Milosavljevic, Assistant Professor, MD PhD

CONTACT

[email protected]

+381638429691

Sponsors and collaborators

Lead sponsor

University of Kragujevac

Other

Registry information

Acronym: MICRORAD

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 8, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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