NCT03315546RecruitingPhase 1/2
Radiotherapy Delivery in Deep Inspiration for Pediatric Patients
Radiotherapy Delivery in Deep Inspiration for Pediatric Patients: TEDDI - a NOPHO Feasibility Study
Source: ClinicalTrials.gov · Last updated 9 Oct 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 14 Sept 2017
- Start date
- 1 Jan 2017
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Childhood cancers
- NCT number
- NCT03315546
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 25
- From 1 Jan 2017 to the primary completion date, 31 Dec 2025
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The need for radiotherapy under general anesthesia.
Age
- Age younger than 5 years or older than 17 years.
Other
- CNS tumor or pelvic localization.
- Unable to understand coaching information directly or through interpretation.
Who the study is looking for
- 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.
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Oncology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Department of Clinical Oncology, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Department of Radiation Oncology, Comprehensive Cancer Center, Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.