None listed
Conditions
Brief summary
This study aims to investigate radiation-related changes in the lungs using a novel, high-resolution imaging modality, in patients with non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are receiving curative intent radiotherapy for non-small cell lung cancer with or without chemotherapy. You should also have had a FDG-PET scan performed for staging of your cancer. Study details: All participants in this study will undergo a Gallium PET scan before radiotherapy treatment, midway through treatment, 3 months after treatment and 12 months after treatment. They will also receive a standard PET scan (similar to the one initially used to diagnose the extent of the cancer) after 3 months after radiotherapy treatment. In addition, lung function tests and 6 minute walk tests will be performed before treatment, mid-way throughout treatment and every 3 months after treatment for up to 12 months. These assessments will enable us to evaluate changes in lung function. By documenting these changes, we aim to better understand the fundamental effects of radiation on pulmonary (lung) physiology, better predict for radiation toxicity, and in the future reduce radiation toxicity by avoiding irradiation of functionally critical segments of lung. In an additional sub-study we will collect blood samples at 5 different timepoints from before treatment to 3 months after radiation treatment, in order to assess radiation induced DNA damage outside of radiation fields.
Interventions
This study aims to investigate radiation-related changes in ventilation and perfusion with 68Ga ventilation-perfusion PET/CT, a novel, high-resolution imaging modality.
A Gallium PET scan will be performed before radiotherapy treatment, midway through treatment, 3 months after treatment and 12 months after treatment.
A standard PET scan, similar to the one initially used to diagnose the extent of the cancer will be performed 3 months after radiotherapy treatment.
Lung spirometry tests (lung func
This study aims to investigate radiation-related changes in ventilation and perfusion with 68Ga ventilation-perfusion PET/CT, a novel, high-resolution imaging modality. A Gallium PET scan will be performed before radiotherapy treatment, midway through treatment, 3 months after treatment and 12 months after treatment. A standard PET scan, similar to the one initially used to diagnose the extent of the cancer will be performed 3 months after radiotherapy treatment. Lung spirometry tests (lung function tests) and 6 minute walk tests will be performed part of this study. In addition to the lung spirometry tests that are performed routinely before and after radiotherapy, lung spirometry will be performed midway through treatment. Walk tests will be performed before treatment, mid-way through treatment and every 3 months after treatment for up to 1 year. In an additional translational sub-study, we propose to assess radiation induced DNA damage outside of radiation fields. These out-of-field effects may be related to systemic effects of radiation, which include nausea and fatigue and also may relate to the risk of secondary malignancy. As part of this study, patients will 4x9mL of blood taken at 5 timepoints during the trial for analysis of DNA damage.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 years. Written informed consent has been provided. FDG-PET scan performed for cancer staging. Patients receiving curative intent radiotherapy for non-small cell lung cancer. Minimum dose of radiotherapy prescribed is 60Gy with or without chemotherapy ECOG performance status 0-2 inclusive
Exclusion criteria
Participant is not able to tolerate supine position on PET/CT bed for the duration of the PET/CT acquisitions, is not cooperative, or needs continuous nursing (e.g. patient from Intensive Care Unit). Pregnancy Breast-feeding
Outcome results
None listed