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Trial registered on ANZCTR


Registration number
ACTRN12616000801415
Ethics application status
Approved
Date submitted
19/05/2016
Date registered
20/06/2016
Date last updated
10/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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).
Scientific title
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
Secondary ID [1] 289244 0
None
Universal Trial Number (UTN)
U1111-1182-9936
Trial acronym
SIMPLE AS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non small cell lung cancer (NSCLC) 298819 0
Oligometastatic disease involving lung 299177 0
Condition category
Condition code
Cancer 298874 298874 0 0
Lung - Non small cell
Cancer 298875 298875 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294784 0
Diagnosis / Prognosis
Comparator / control treatment
No control group - all patients will receive the same investigations.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298346 0
To qualitatively assess post SABR tumour response which will be determined through radiological assessment (MRI scans with or without PET-CT) and physical examination.
Timepoint [1] 298346 0
6 monthly up to 24 months following radiotherapy treatment.
Primary outcome [2] 298455 0
To quantitatively assess post SABR tumour response which will be determined through radiological assessment (MRI scans with or without PET-CT) and physical examination.
Timepoint [2] 298455 0
6 monthly up to 24 months following radiotherapy treatment.
Secondary outcome [1] 323901 0
Assess validity of the Dahele scale for post-SABR tumour changes determined through CT scans.
Timepoint [1] 323901 0
3 months and 6 monthly following radiotherapy treatment up to 24 months.
Secondary outcome [2] 323902 0
To develop a method for standardized synoptic reporting of post-SABR tumour changes on MRI and PET-CT which will be determined through quantitative and qualitative assessment of all available imaging.
Timepoint [2] 323902 0
24 months after the last patient has completed their radiotherapy treatment.
Secondary outcome [3] 323903 0
To develop a ‘scoring system’ for MRI and PET-CT based assessment post-SABR which will be determined through quantitative and qualitative assessment of all available imaging.
Timepoint [3] 323903 0
24 months after the last patient has completed their radiotherapy treatment.
Secondary outcome [4] 324164 0
To qualitatively assess post-SABR effects on normal tissues which will be determined through radiological assessment (MRI scans with or without PET-CT) and physical examination.
Timepoint [4] 324164 0
6 monthly up to 24 months following radiotherapy treatment.
Secondary outcome [5] 324165 0
To quantitatively assess post-SABR effects on normal tissues which will be determined through radiological assessment (MRI scans with or without PET-CT) and physical examination.
Timepoint [5] 324165 0
6 monthly up to 24 months following radiotherapy treatment.

Eligibility
Key inclusion criteria
Patients undergoing SABR for Stage I/II NSCLC or lung oligometastases
Able to attend follow up for 2 years
Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prognosis less than 2 years
Patient refusal
Contraindication to MRI
Inability to give informed consent
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5809 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 5810 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 5811 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 13250 0
2170 - Liverpool
Recruitment postcode(s) [2] 13251 0
2560 - Campbelltown
Recruitment postcode(s) [3] 13252 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 293622 0
Hospital
Name [1] 293622 0
Liverpool Cancer Services Trust Fund
Address [1] 293622 0
1 Elizabeth St, Liverpool NSW 2170
Country [1] 293622 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
1 Elizabeth St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 292453 0
Individual
Name [1] 292453 0
Dr Andrew Oar
Address [1] 292453 0
Liverpool Cancer Therapy
Liverpool Hospital
1 Campbell St Liverpool
NSW 2170
Country [1] 292453 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295060 0
South Western Sydney Local Health District
Ethics committee address [1] 295060 0
Research and Ethics Office
Locked Bag 7103
Liverpool BC
NSW 1871
Ethics committee country [1] 295060 0
Australia
Date submitted for ethics approval [1] 295060 0
25/01/2016
Approval date [1] 295060 0
07/06/2016
Ethics approval number [1] 295060 0
HREC/16/LPOOL/41

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65946 0
Prof Shalini Vinod
Address 65946 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 65946 0
Australia
Phone 65946 0
+61 2 8738 9806
Fax 65946 0
+61 2 8738 9811
Email 65946 0
shalini.vinod@health.nsw.gov.au
Contact person for public queries
Name 65947 0
Prof Shalini Vinod
Address 65947 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 65947 0
Australia
Phone 65947 0
+61 2 8738 9806
Fax 65947 0
+61 2 8738 9811
Email 65947 0
shalini.vinod@health.nsw.gov.au
Contact person for scientific queries
Name 65948 0
Prof Shalini Vinod
Address 65948 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 65948 0
Australia
Phone 65948 0
+61 2 8738 9806
Fax 65948 0
+61 2 8738 9811
Email 65948 0
shalini.vinod@health.nsw.gov.au

No information has been provided regarding IPD availability
Attachments/websites
Type [1] 1251 0
Study protocol
URL/details/comments [1] 1251 0
Summary results
No Results