Tests a breath-hold radiotherapy technique in children with cancer
Tests breath-hold radiation delivery in children with cancer needing chest or belly radiotherapy.
Plain-language title generated from the registry record
Registry title: Radiotherapy Delivery in Deep Inspiration for Pediatric Patients
Key facts
- Where
- Aarhus and Copenhagen, DenmarkSee the 2 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 17 years old?
Source: NCT03315546, who can take part
Where in Denmark
- Department of Clinical Oncology, Aarhus University HospitalAarhus, DenmarkTaking people
- Department of Clinical Oncology, RigshospitaletCopenhagen, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Trial code
- NCT03315546
- Record updated
- 9 October 2020
- Original description
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.Read full original descriptionShow less
Radiotherapy Delivery in Deep Inspiration for Pediatric Patients: TEDDI - a NOPHO Feasibility Study
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.
Inclusion: 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: The need for radiotherapy under general anesthesia; Age younger than 5 years or older than 17 years; CNS tumor or pelvic localization; Unable to understand coaching information directly or through interpretation.