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

July 13, 2026 updated by: Marija Zivkovic Radojevic, University of Kragujevac

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with head and neck malignancies undergoing radiation therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the 6 month FU treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kragujevac

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICRORAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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