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Clinical Trials in Denmark / NCT03315546
Recruiting Phase 1/2

Radiotherapy Delivery in Deep Inspiration for Pediatric Patients

NCT03315546 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 1/2
Started
2017-01-01
Last updated
2020-10-09

Condition(s) studied

Pediatric Cancer

Investigational drug(s) / intervention(s)

radiotherapy delivery in deep-inspiration

radiotherapy delivery in deep-inspiration: Radiotherapy delivery i deep-inspiration versus free-breathing

Study 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

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Department of Clinical Oncology, Rigshospitalet Copenhagen Danmark Recruiting
Department of Clinical Oncology, Aarhus University Hospital Aarhus Denmark Recruiting
Department of Radiation Oncology, Comprehensive Cancer Center, Helsinki University Hospital Helsinki Finland Recruiting

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03315546 on ClinicalTrials.gov ↗ ← All trials in Denmark