Radiotherapy for pediatric cancer using deep inspiration breath-hold technique
Official title: Radiotherapy Delivery in Deep Inspiration for Pediatric Patients: TEDDI - a NOPHO Feasibility Study
Run by Copenhagen University Hospital, Rigshospitalet · NCT03315546 · Data updated 2026-11-12
This study is testing a breathing technique during radiation therapy to see if it can help protect healthy organs in children with tumors in their chest or abdomen.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Copenhagen, Danmark and 2 other locations) |
| Status | Recruiting |
| Started | January 1, 2017 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2029 |
| Registry record updated | October 9, 2020 |
| Trial ID | NCT03315546 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric patients aged 5-17 years with tumors in the mediastinum or abdomen who require radiotherapy.
✕Probably not a fit
Patients younger than 5 years, older than 17 years, or those requiring radiotherapy under general anesthesia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the use of deep inspiration breath-hold (DIBH) during radiotherapy for pediatric patients with tumors in the thorax or abdomen. The study aims to assess the dosimetric benefits of DIBH compared to traditional free-breathing techniques, focusing on reducing radiation exposure to healthy organs and minimizing late effects. Participants will be coached to perform sequential breath-holds during treatment, and the study will also evaluate compliance and reproducibility of this technique. The trial is non-randomized and includes pediatric patients aged 5-17 years, regardless of cancer diagnosis.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of long-term radiation-induced health issues in pediatric cancer survivors.
How similar studies have gone: Previous studies in adults have shown success with DIBH techniques, but this application in pediatric patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 5-17 years. * Patients with a tumor in the mediastinum or abdomen with possible need of radiotherapy according to current treatment guidelines, irrespective of cancer diagnosis. * The ability to perform three sequential breath-holds of 20 seconds each during the coaching session. * Written informed consent from parents or legal guardians. Exclusion Criteria: * Age younger than 5 years or older than 17 years. * The need for radiotherapy under general anesthesia. * CNS tumor or pelvic localization. * Unable to understand coaching information directly or through interpretation.
Where it's running
-
Department of Clinical Oncology, Rigshospitalet
Copenhagen, Danmark, Denmark Recruiting -
Department of Clinical Oncology, Aarhus University Hospital
Aarhus, Denmark Recruiting -
Department of Radiation Oncology, Comprehensive Cancer Center, Helsinki University Hospital
Helsinki, Finland Recruiting
Study contacts
- Study coordinator: Maja V Maraldo, MD, PhD
- Email: maja.vestmoe.maraldo@regionh.dk
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.