Clinical trial · Interventional
Radiotherapy Delivery in Deep Inspiration for Pediatric Patients
Radiotherapy Delivery in Deep Inspiration for Pediatric Patients: TEDDI - a NOPHO Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy delivery in deep-inspiration | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The dosimetric benefit of DIBH
- timeFrame
- 1 day prior to treatment start, the superior radiation treatment plan is chosen for treatment delivery
- description
- For each patient, the radiation treatment plan calculated in DIBH and in FB will be compared
Secondary outcomes (3)
- measure
- Patient compliance defined as 1) patient comfort
- timeFrame
- Through study completion, an average of 1 month total treatment time
- description
- Patient comfort will be assessed through questionnaires (after first, middle and last treatment fraction) which aim to evaluate the level of information and coaching pre-treatment, the physical treatment environment at the departments, and the health care staff.
- measure
- Patient compliance defined as 2) breathhold reproducibility
- timeFrame
- Through study completion, an average of 1 month total treatment time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDLundgaard AY, Dejanovic D, Berthelsen AK, Andersen FL, Rechner LA, Borgwardt L, Hjalgrim LL, Specht L, Maraldo MV. Baseline FDG PET/CT in free breathing versus deep inspiration breath-hold for pediatric patients with mediastinal lymphoma. Acta Oncol. 2022 Feb;61(2):239-246. doi: 10.1080/0284186X.2021.1974554. Epub 2021 Sep 17. PMID 34533416
- DERIVEDLundgaard AY, Josipovic M, Rechner LA, Bidstrup PE, Hansen R, Damkjaer SS, Joergensen M, Safwat A, Specht L, Hjalgrim LL, Maraldo MV. The Feasibility of Implementing Deep Inspiration Breath-Hold for Pediatric Radiation Therapy. Int J Radiat Oncol Biol Phys. 2020 Apr 1;106(5):977-984. doi: 10.1016/j.ijrobp.2019.12.025. Epub 2020 Jan 28. PMID 32005489
- DERIVEDLundgaard AY, Hjalgrim LL, Rechner LA, Josipovic M, Joergensen M, Aznar MC, Berthelsen AK, Borgwardt L, Johansen C, Loft A, Safwat A, Vaalavirta L, Specht L, Maraldo MV. TEDDI: radiotherapy delivery in deep inspiration for pediatric patients - a NOPHO feasibility study. Radiat Oncol. 2018 Mar 27;13(1):56. doi: 10.1186/s13014-018-1003-4. PMID 29587881