Head and Neck CancerMICRORADNCT07690631
Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:
An observational study of Head and Neck Cancer and Microplastic Exposure, run by University of Kragujevac.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Microplastic Exposure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with head and neck malignancies undergoing radiation therapy
Who may be able to join
- Any stage head and neck cancer patients
- Eastern Cooperative Oncology Group performance status 0-2
- Undergoing radiotherapy with/without cisplatin chemopotentiation
- Signed informed consent
Who cannot join
- Pregnancy or lactation
- Mental illness
- Prior or concurrent malignancies
- Immunotherapy or immunosuppressive therapy
- Immune diseases
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marija N Zivkovic Radojevic, Assistant Professor, MD PhD contact
About this 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.
Read more
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.
- Conditions
- Head and Neck Cancer, Microplastic Exposure
- Keywords
- Head and neck cancer, Microplastics, thermoplastics mask, MICRORAD, MNPs
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
MNPs effect on head and neck cancer patiens
To characterize MNPs and trace their biodistribution and to correlate MNP exposure with treatment outcomes
Measured: From enrollment to the 6 month FU treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startFeb 2027 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kragujevac
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marija Zivkovic Radojevic, University of Kragujevac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690631
- Sponsor's protocol ID
- MICRORAD
- Acronym
- MICRORAD
- Status last verified
- Nov 2026
- First submitted
- 1 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic MICROplastic Exposure on RADiotherapy of Head and Neck Cancer Patients: Clinical and Translational Oncology Study:
- ClinicalTrials.gov ID
- NCT07690631
- Acronym / sponsor ID
- MICRORAD / MICRORAD
- Conditions
- Head and Neck Cancer, Microplastic Exposure
- Keywords
- Head and neck cancer, Microplastics, thermoplastics mask, MICRORAD, MNPs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of KragujevacUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck malignancies undergoing radiation therapy
Key inclusion criteria (4 listed)
- Any stage head and neck cancer patients
- Eastern Cooperative Oncology Group performance status 0-2
- Undergoing radiotherapy with/without cisplatin chemopotentiation
- Signed informed consent
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Mental illness
- Prior or concurrent malignancies
- Immunotherapy or immunosuppressive therapy
- Immune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marija N Zivkovic Radojevic, Assistant Professor, MD PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Microplastic Exposure, run by University of Kragujevac.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marija N Zivkovic Radojevic, Assistant Professor, MD PhD (+381658384450, makizivkovicmarija@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MNPs effect on head and neck cancer patiens (time frame: From enrollment to the 6 month FU treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.