Actively Recruiting
Radiotherapy Delivery in Deep Inspiration for Pediatric Patients
Led by Rigshospitalet, Denmark · Updated on 2020-10-09
25
Participants Needed
3
Research Sites
678 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radiotherapy Delivery in Deep Inspiration for Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5-17 years
- Tumor in the mediastinum or abdomen needing radiotherapy according to guidelines
- Ability to perform three sequential breath-holds of 20 seconds each during coaching
- Written informed consent from parents or legal guardians
You will not qualify if you...
- Age younger than 5 years or older than 17 years
- Need for radiotherapy under general anesthesia
- Tumor located in the central nervous system (CNS) or pelvis
- Unable to understand coaching information directly or through interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Department of Clinical Oncology, Rigshospitalet
Copenhagen, Danmark, Denmark, 2100
Actively Recruiting
2
Department of Clinical Oncology, Aarhus University Hospital
Aarhus, Denmark, 8000
Actively Recruiting
3
Department of Radiation Oncology, Comprehensive Cancer Center, Helsinki University Hospital
Helsinki, Finland, 00290
Actively Recruiting
Research Team
M
Maja V Maraldo, MD, PhD
CONTACT
A
Anni YS Jørgensen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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