NCT03315546: TEDDI

Radiotherapy Delivery in Deep Inspiration for Pediatric Patients

Recruiting now Phase 1, PHASE2 Last updated 9 October 2020

What this trial tests

Phase 1, PHASE2 trial testing radiotherapy delivery in deep-inspiration in Pediatric Cancer in 25 participants. Currently enrolling.

Timeline

1 January 2017

Primary endpoint
31 December 2025

31 December 2029

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 January 2017
Primary completion	31 December 2025
Estimated completion	31 December 2029
Sites	3 locations across Denmark, Finland

Drugs / interventions tested

• radiotherapy delivery in deep-inspiration

Conditions studied

• Pediatric Cancer — all drugs for Pediatric Cancer →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 5 to 17, any sex, with Pediatric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. TEDDI: radiotherapy delivery in deep inspiration for pediatric patients - a NOPHO feasibility study.
   Lundgaard AY, Hjalgrim LL, Rechner LA, Josipovic M, et al · · 2018 · cited 9× · PMID 29587881 · DOI 10.1186/s13014-018-1003-4
2. The Feasibility of Implementing Deep Inspiration Breath-Hold for Pediatric Radiation Therapy.
   Lundgaard AY, Josipovic M, Rechner LA, Bidstrup PE, et al · · 2020 · cited 8× · PMID 32005489 · DOI 10.1016/j.ijrobp.2019.12.025
3. Proton linear energy transfer and variable relative biological effectiveness for adolescent patients with Hodgkin lymphoma.
   Rechner LA, Maraldo MV, Smith EA, Lundgaard AY, et al · · 2023 · cited 4× · PMID 37035769 · DOI 10.1259/bjro.20230012
4. Baseline FDG PET/CT in free breathing versus deep inspiration breath-hold for pediatric patients with mediastinal lymphoma.
   Lundgaard AY, Dejanovic D, Berthelsen AK, Andersen FL, et al · · 2022 · cited 3× · PMID 34533416 · DOI 10.1080/0284186x.2021.1974554