Radiotherapy Delivery in Deep Inspiration for Pediatric Patients

NCT03315546 | Recruiting Phase 1

• 1 other identifier: H-16035870
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Pediatric Cancer

Keywords

deep inspiration breath-hold; radiotherapy; late effects; pediatric cancer

Outcome Measures

Primary Outcomes (1)

• The dosimetric benefit of DIBH

  For each patient, the radiation treatment plan calculated in DIBH and in FB will be compared

  1 day prior to treatment start, the superior radiation treatment plan is chosen for treatment delivery

Secondary Outcomes (3)

• Patient compliance defined as 1) patient comfort

  Through study completion, an average of 1 month total treatment time

• Patient compliance defined as 2) breathhold reproducibility

  Through study completion, an average of 1 month total treatment time

• The accuracy of the treatment delivery

  Through study completion, an average of 1 month total treatment time

Interventions

radiotherapy delivery in deep-inspiration RADIATION

Radiotherapy delivery i deep-inspiration versus free-breathing

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator
• Tampere University Hospital: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (3)

Department of Clinical Oncology, Rigshospitalet

Copenhagen, Danmark, 2100, Denmark

RECRUITING

Department of Clinical Oncology, Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Department of Radiation Oncology, Comprehensive Cancer Center, Helsinki University Hospital

Helsinki, 00290, Finland

RECRUITING

Related Publications (3)

• Lundgaard 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 DERIVED

• Lundgaard 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 DERIVED

• Lundgaard 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 DERIVED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Maja V Maraldo, MD, PhD

CONTACT

maja.vestmoe.maraldo@regionh.dk

Anni YS Jørgensen, MD

CONTACT

anni.young.lundgaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: non-randomised feasiblity study

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: October 20, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); FI (1)