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SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.

CT-based radiation therapy given over 5- 6.5 weeks.

SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung

Single-photon-emission CT scan

Katherina Farr, MD PhD

Eric Hau, MBBS PhD

Azza Khalil, MD, PhD

Line Sparvath

Katherina Farr, MD, PhD

Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.

In this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. Functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. Radiotherapy is usually based on a CT scan that does not account for functional variations in the lungs. Therefore, I hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer.

The objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial.

To reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed. Additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.

Participants, care providers and outcome assessors are blinded

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial

crude rate of symptomatic radiation-induced lung toxicity of grade 2 and higher. According to the Common Toxicity Criteria for Adverse Events version 5.0 for radiation pneumonitis, dyspnea, cough, or any other radiation-induced respiratory, thoracic and mediastinal disorder.

Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires

Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire

time from randomization to disease progression at any site or death

time from randomization to death of any cause or last date known alive

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer	NCT04676828	Lung Cancer Radiation-Induc... Radiation Pneum... Pulmonary Disea... Lung Function D...	Single-photon-e...	18 Years -	University of Aarhus
Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer	NCT04676828	Lung Cancer Radiation-Induc... Radiation Pneum... Pulmonary Disea... Lung Function D...	Single-photon-e...	18 Years -	University of Aarhus

Spots Global Cancer Trial Database for radiation therapy of lung cancer