NCT03315546 Radiotherapy Delivery in Deep Inspiration for Pediatric Patients
| NCT ID | NCT03315546 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Copenhagen University Hospital, Rigshospitalet |
| Condition | Pediatric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2017-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2017-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
TEDDI is a non-randomised phase II trial in Scandinavia. All pediatric patients, referred for radiotherapy in the thorax or abdomen and irrespective of diagnosis, are eligible. Deep inspiration breath-hold (DIBH) is a simple radiotherapy technique, which could have a dramatic impact on the risk of late effects in children. In DIBH, the radiotherapy is delivered while the patient holds his/her breath (4-6 sequential breath-holds). The anatomy is changed and imaging artifacts from respiratory movement are diminished. DIBH is widely used in adult patients with breast cancer and mediastinal lymphoma to minimize the risk of radiation-induced late effects due to a reduced dose to the healthy organs. Also, the technique is simple and cost-efficient. For pediatric patients, the investigators aim to: * Estimate the dosimetric benefit of radiotherapy using DIBH compared to free-breathing * Establish the compliance of DIBH * Determine if DIBH is an accurate and reproducible strategy * Optimize treatment planning considering the risk from loss of tumour control as well as the risk of late effects.
Eligibility 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.
Contact & Investigator
Maja V Maraldo, MD, PhD
✉ maja.vestmoe.maraldo@regionh.dkFrequently Asked Questions
Who can join the NCT03315546 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Pediatric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03315546 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03315546 currently recruiting?
Yes, NCT03315546 is actively recruiting participants. Contact the research team at maja.vestmoe.maraldo@regionh.dk for enrollment information.
Where is the NCT03315546 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Aarhus, Denmark, Helsinki, Finland.
Who is sponsoring the NCT03315546 clinical trial?
NCT03315546 is sponsored by Copenhagen University Hospital, Rigshospitalet. The trial plans to enroll 25 participants.
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