A study looking at the use of multiparametric Magnetic Resonance Imaging (MRI) and Positron Emission Tomography - Computed Tomography (PET-CT) to evaluate radiological changes after lung stereotactic ablative radiotherapy (SABR).
Use of multiparametric Magnetic Resonance Imaging (MRI) and Positron Emission Tomography - Computed Tomography (PET-CT) to evaluate radiological changes after lung Stereotactic Ablative Radiotherapy (SABR) in patients with stage I/II non-small cell lung cancer (NSCLC) or lung oligometastases
Liverpool Hospital
30 participants
Jun 1, 2017
Interventional
Conditions
Summary
This study will qualitatively and quantitatively assess MRI and PET-CT for the surveillance of patients with early stage Non-Small Cell Lung Cancer (NSCLC) or pulmonary oligometastatic disease treated with SABR. Similarly, it will also qualitatively and quantitatively assess the changes that occur in normal tissues after delivery of SABR. We intend to assess the validity of current recommendations that utilise CT and PET-CT, and to explore whether or not MRI adds anything to current recommendations. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with Stage I or II NSCLC or pulmonary oligometastatic disease. Study details: All patients who are enrolled in the study will receive the standard pre-treatment work-up, treatment and post treatment surveillance. In addition patients will be subjected to six additional MRIs and two additional PET-CTs and PFTs. In addition patients will be subjected to six additional MRIs and two additional PET-CTs and PFTs, conducted up to 24 months following radiotherapy treatment. This will best identify patients and/or circumstances where PET-CT and/or MRI are of additional value to the standard surveillance protocol currently recommended.
Eligibility
Inclusion Criteria3
- Patients undergoing SABR for Stage I/II NSCLC or lung oligometastases
- Able to attend follow up for 2 years
- Over 18 years of age
Exclusion Criteria5
- Prognosis less than 2 years
- Patient refusal
- Contraindication to MRI
- Inability to give informed consent
- Pregnancy
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Interventions
The intervention involved in this study is six additional Magnetic Resonance Imaging (MRI) scans (approximately 45 minutes each), two additional Positron Emission Tomography - Computed Tomography (PET-CT) scans (approximately 4 hours each) and two pulmonary functions tests (PFTs) (approximately 30 minutes each). The MRI scans will involve the use of a contrast agent administered intravenously by the treating doctor, unless contraindicated then no contrast will be used. The MRI scan will be performed by a suitably qualified allied health professional. The PET-CT scan involves the use of an intravenously administered radioactive drug (tracer) followed by the scan. The PET-CT scan will be performed by a suitably qualified allied health professional. The PFTs involve a series of tests that measure how well the participant’s lungs work. The MRI scans will be performed before and in the follow up stage after radiotherapy treatment over approximately a 24 month period. This includes MRI scans performed at least one week prior to radiotherapy treatment, and then 3, 6, 12, 18 and 24 months after radiotherapy treatment is finished. The study related PET-CT scans will be performed 6 and 18 months after radiotherapy treatment is finished. The study related PFTs will be performed 12 and 24 months after radiotherapy treatment is finished. ALL MRI scans performed before or after the radiotherapy treatment are for the assessment of tumour and treatment response. For the investigational PET-CT and MRI scan performed at 6 and 18 months after radiotherapy treatment, these will be performed within a few days of each other at the same hospital but in different departments. For the investigational MRI scan and PFTs performed at 12 and 24 months after radiotherapy treatment, these will be performed within a few days of each other at the same hospital but in different departments. All other investigational MRI scans will be performed on the same day as the routine clinic visit. The clinical trials team will document compliance of attendance at scheduled imaging. Patients who have not attended their scheduled imaging will be contacted by the clinical trials team and reasons for failure to attend will be sought. Where possible, attendance to reschedule appointments will be facilitated.
Locations(3)
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ACTRN12616000801415