Multi -paramEtric Imaging to Assess Treatment REsponse After Stereotactic Radiosurgery of Brain Metastases

NCT04626206 | Unknown

• 1 other identifier: CCR5331
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

After stereotactic radiosurgery (SRS) of brain metastases, patients undergo a standard brain magnetic resonance imaging (MRI) to assess treatment response 12 weeks after completion of treatment. The interpretation of this standard MRI can sometimes be challenging as it can be difficult to differentiate tumour getting bigger/returning (progression/recurrence) from expected radiotherapy treatment-related changes known as radionecrosis. This study is a pilot brain imaging study that is investigating if readily available forms of imaging such as contrast-clearance analysis MRI (also known as TRAMs) and/or 18 Fluoromethyl-choline positron emission tomography/computerised tomography (18F-choline PET/CT) are equivalent to multi-parametric MRI in their ability to differentiate tumour from radionecrosis. Multi-parametric MRI has the most evidence for its ability to discriminate tumour from radionecrosis but is resource intensive and not routinely available in most centres.

Conditions

Brain Metastases, Adult

Keywords

brain metastases; stereotactic radiosurgery; multi-parametric MRI; contrast-clearance analysis MRI; TRAMs; 18F-choline PET/CT; treatment response

Outcome Measures

Primary Outcomes (1)

• Equivalence of the contrast-clearance analysis MRI (TRAMs) and/or 18F-Choline PET/CT to multi-parametric MRI in differentiating tumour progression/recurrence from radionecrosis post stereotactic radiosurgery of brain metastases.

  Patients will be classified into two groups according to the result of each scan with either tumour progression/recurrence or radionecrosis (i.e. tumour or no tumour). Patients will have all three scans within two weeks of each other, and then each imaging technique will be reviewed and reported by neuroradiologists as either disease or no disease. All three scans will be assessed once. The sensitivity, specificity, positive and negative predictive values in detecting tumour and prevalence will be calculated for the two scan methods where multi-parametric MRI will be used as the definitive diagnosis as we consider this as the gold standard in this study. The two scan methods are contrast-clearance analysis MRI (TRAMs) and 18F-choline PET/CT classification (tumour or no tumour) which will be compared against multi-parametric MRI. These separate measurements will be aggregated to obtain the primary outcome measurement (equivalence).

  Primary outcome will be measured after the last visit of last patient-about 8 months from first recruited patient.

Secondary Outcomes (2)

• Secondary endpoints are exploratory and will focus on correlating quantitative imaging derived parameters from contrast-clearance analysis MRI (TRAMs) and 18F-choline PET/CT with quantitative parameters in multi-parametric MRI.

  This can be measured after the last visit of last patient-about 8 months from first recruited patient.

• Correlation of the three scan results with the actual clinical outcomes for the patients-ie tumour or radionecrosis.

  Analysed only after a follow-up period of at least 6 months for all patients post completion of study investigations-about 14 months from first recruited patient and 6 months from last recruited patient.

Study Arms (1)

Imaging to asess treatment response post-SRS

There will be only one group. All recruited patients will have 3 scans, the multi-parametric MRI, contrast-clearance analysis MRI (TRAMs) and 18F-choline-PET/CT. This is a non interventional study. Only the results of the contrast-clearance analysis MRI (TRAMs) will be used to make clinical decisions (as this is the current standard of care at the recruiting site). The multi-parametric MRI and 18F-choline PET/CT will be treated as research scans.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non-small cell lung cancer patients with brain metastases who have undergone primary stereotactic radiosurgery for their brain metastases. These patients have had a follow up standard brain MRI to assess treatment response and this has been discussed in the stereotactic radiosurgery multidisciplinary team meeting (MDT) and the MDT has deemed that the changes seen are unclear as to whether they represent tumour progression or radionecrosis.

You may qualify if:

• Patients with brain metastases whose primary cancer originates from the lung and whose histology is that of non-small cell lung cancer (NSCLC)
• Patient should have had SRS as their primary treatment for their brain metastases
• Follow-up standard brain MRI post-SRS has been discussed in the SRS multi-disciplinary team meeting (MDT)
• The changes seen on the post-SRS follow-up standard MRI are deemed unclear by the SRS MDT as to whether they represent tumour progression or radionecrosis.
• It is \>=12 weeks since completion of SRS

You may not qualify if:

• Prior SRS or external beam radiotherapy to the same area
• Children (age \< 18)
• Pregnant women
• Adults that lack capacity to consent
• Contraindications to intravenous gadolinium contrast and/or 18F-choline radiotracer
• Contraindications to MRI scanning (for example pacemaker )

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Related Publications (24)

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  BACKGROUND

• NHS England. D05/S/a NHS STANDARD CONTRACT FOR STEREOTACTIC RADIOSURGERY AND STEREOTACTIC RADIOTHERAPY (INTRACRANIAL) (ALL AGES) SCHEDULE 2- THE SERVICES - A. SERVICE SPECIFICATIONS. 2013;800(October):1-26.

  BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liam Welsh, MBBS,FRCR

  Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bharthi Kanagaratnam, MBBS,FRCR

CONTACT

02078082271; Bharthi.kanagaratnam@rmh.nhs.uk

Kathy Greenwood, Bsc

CONTACT

02086613300; Kathy.Greenwood@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 12, 2020
• Study Start: December 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share