Radiotherapy Delivery in Deep Inspiration for Pediatric Patients
Recruiting now · Phase 1/Phase 2
Conditions studied: Pediatric Cancer
In brief
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.
Key facts
- Study ID
- NCT03315546
- Run by
- Rigshospitalet, Denmark
- People needed
- 25
- Starts
- 2017-01-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2020-10-09
Who can join
Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Department of Clinical Oncology, Rigshospitalet — Copenhagen, Danmark, Denmark (enrolling)
- Department of Clinical Oncology, Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Department of Radiation Oncology, Comprehensive Cancer Center, Helsinki University Hospital — Helsinki, Finland (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.