Brain Metastases, AdultMETRENCT04626206
Multi -paramEtric Imaging to Assess Treatment REsponse After Stereotactic Radiosurgery of Brain Metastases
An observational study of Brain Metastases, Adult, run by Royal Marsden NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 )
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multi-paramEtric Imaging to Assess Treatment REsponse After Stereotactic Radiosurgery of Brain Metastases
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.
Read the detailed description
Differentiating tumour progression/recurrence from radionecrosis post- stereotactic radiosurgery (SRS) of brain metastases can be at times challenging on standard brain MRI. This is because radionecrosis mimics the appearances of tumour progression by appearing as contrast enhancing lesions on standard MRI.The definitive way of differentiating this is surgical excision of the area in question and histopathological evaluation. But this is not always feasible in clinical practice as not all areas of the brain are surgically accessible and an en bloc (complete) resection is needed for the result to be meaningful.
The next best option we have is the multi-parametric MRI which typically consists of three components-MR perfusion, MR diffusion and MR spectroscopy. This investigation is resource intensive, requiring considerable input form MR physics, neuroradiology reporting time , is not routinely available in all centres and hence not viable for routine clinical practice.
Therefore there is an urgent need for a reliable and viable form of imaging modality that helps differentiate tumour from radionecrosis when assessing treatment response post-SRS. It is important to be able to do this accurately as the management of both conditions are entirely different.
Currently the Royal Marsden Hospital is using contrast-clearance analysis MRI (TRAMs) to help differentiate tumour from radionecrosis if the changes seen on standard brain MRI post-SRS are deemed to be unclear. Contrast-clearance analysis MRI (TRAMs) is FDA approved and conforms to European standards (CE marked), yet has sparse evidence on its efficacy. There is some evidence for the use of 18F-choline PET/CT in primary brain tumours (gliomas) but more evidence is needed for its use in brain metastases.
Given that surgical excision is not always feasible for reasons explained above, in this study the investigators consider the muti-parametric MRI as the gold standard investigation for discriminating tumour from radionecrosis.
This pilot brain imaging study is seeking to determine if contrast-clearance analysis MRI (TRAMs) and/or 18F-choline PET/CT are equivalent to multi-parametric MRI in their ability to reliably differentiate between tumour progression/recurrence and radionecrosis. If contrast clearance analysis MRI (TRAMs) and/or 18F-choline PET/CT are found to be equivalent to multi- parametric MRI then it gives the investigators increased confidence in the findings of these readily available imaging modalities, helping treating clinicians to make rapid and reliable management plans- ultimately improving patient outcomes.
- Conditions
- Brain Metastases, Adult
- Keywords
- brain metastases, stereotactic radiosurgery, multi-parametric MRI, contrast-clearance analysis MRI, TRAMs, 18F-choline PET/CT, treatment response
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Each imaging technique, multi-parametric MRI (this scan has 3 components), contrast-clearance analysis MRI (TRAMs) and 18F-choline PET, measures different quantitative parameters to assess for the presence of tumour. Examples of quantitative parameters include for multi-parametric MRI: relative cerebral blood volume, apparent diffusion coefficient, choline to n-acetylcysteine ratio; contrast-clearance analysis MRI (TRAMs): volume of red versus blue areas on the treatment assessment maps; 18F-Choline PET: uptake value of the 18F-choline. These separate measurements will be aggregated to measure a single outcome, outcome 2 which is - is there a correlation between quantitative parameters from TRAMs and 18F-choline PET/CT and multi-parametric MRI.
Measured: 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.
Results from the three imaging modalities contrast-clearance analysis MRI (TRAMs), 18F-choline PET/CT, multi-parametric MRI, will be compared with the actual clinical outcomes for the patients (i.e. tumour progression/recurrence or radionecrosis) which will be known with more certainty after a period of follow-up of 6 months has elapsed following the study imaging investigations. This follow-up involves collecting routine standard brain MRI scan results (reports and/or images) and clinical review letters from the primary team.
The sensitivity, specificity, positive and negative predictive values in detecting tumour and prevalence for the three scan methods will be compared against actual clinical outcomes. These separate measurements will be aggregated to measure outcome 3, which is - is there a correlation between the three scans and actual clinical outcomes for the patient.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Liam Welsh, MBBS,FRCR, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626206
- Sponsor's protocol ID
- CCR5331
- Acronym
- METRE
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stelzer KJ. Epidemiology and prognosis of brain metastases. Surg Neurol Int. 2013 May 2;4(Suppl 4):S192-202. doi: 10.4103/2152-7806.111296. Print 2013.
PubMed 23717790Lowery FJ, Yu D. Brain metastasis: Unique challenges and open opportunities. Biochim Biophys Acta Rev Cancer. 2017 Jan;1867(1):49-57. doi: 10.1016/j.bbcan.2016.12.001. Epub 2016 Dec 6.
PubMed 27939792Hoffman JM. New advances in brain tumor imaging. Curr Opin Oncol. 2001 May;13(3):148-53. doi: 10.1097/00001622-200105000-00003.
PubMed 11307056Hein PA, Eskey CJ, Dunn JF, Hug EB. Diffusion-weighted imaging in the follow-up of treated high-grade gliomas: tumor recurrence versus radiation injury. AJNR Am J Neuroradiol. 2004 Feb;25(2):201-9.
PubMed 14970018Sundgren PC, Fan X, Weybright P, Welsh RC, Carlos RC, Petrou M, McKeever PE, Chenevert TL. Differentiation of recurrent brain tumor versus radiation injury using diffusion tensor imaging in patients with new contrast-enhancing lesions. Magn Reson Imaging. 2006 Nov;24(9):1131-42. doi: 10.1016/j.mri.2006.07.008. Epub 2006 Sep 18.
PubMed 17071335Matsusue E, Fink JR, Rockhill JK, Ogawa T, Maravilla KR. Distinction between glioma progression and post-radiation change by combined physiologic MR imaging. Neuroradiology. 2010 Apr;52(4):297-306. doi: 10.1007/s00234-009-0613-9. Epub 2009 Oct 16.
PubMed 19834699Rock JP, Scarpace L, Hearshen D, Gutierrez J, Fisher JL, Rosenblum M, Mikkelsen T. Associations among magnetic resonance spectroscopy, apparent diffusion coefficients, and image-guided histopathology with special attention to radiation necrosis. Neurosurgery. 2004 May;54(5):1111-7; discussion 1117-9. doi: 10.1227/01.neu.0000119328.56431.a7.
PubMed 15113465Zach L, Guez D, Last D, Daniels D, Grober Y, Nissim O, Hoffmann C, Nass D, Talianski A, Spiegelmann R, Tsarfaty G, Salomon S, Hadani M, Kanner A, Blumenthal DT, Bukstein F, Yalon M, Zauberman J, Roth J, Shoshan Y, Fridman E, Wygoda M, Limon D, Tzuk T, Cohen ZR, Mardor Y. Delayed contrast extravasation MRI: a new paradigm in neuro-oncology. Neuro Oncol. 2015 Mar;17(3):457-65. doi: 10.1093/neuonc/nou230. Epub 2014 Nov 30.
PubMed 25452395Chen K, Chen X. Positron emission tomography imaging of cancer biology: current status and future prospects. Semin Oncol. 2011 Feb;38(1):70-86. doi: 10.1053/j.seminoncol.2010.11.005.
PubMed 21362517Nanni C, Rubello D, Fanti S. Could choline PET play a role in malignancies other than prostate cancer? Eur J Nucl Med Mol Imaging. 2008 Jan;35(1):216-8. doi: 10.1007/s00259-007-0591-2. Epub 2007 Sep 26. No abstract available.
PubMed 17899074Zeisel SH, Blusztajn JK. Choline and human nutrition. Annu Rev Nutr. 1994;14:269-96. doi: 10.1146/annurev.nu.14.070194.001413.
PubMed 7946521Fagone P, Jackowski S. Phosphatidylcholine and the CDP-choline cycle. Biochim Biophys Acta. 2013 Mar;1831(3):523-32. doi: 10.1016/j.bbalip.2012.09.009. Epub 2012 Sep 23.
PubMed 23010477Treglia G, Sadeghi R, Del Sole A, Giovanella L. Diagnostic performance of PET/CT with tracers other than F-18-FDG in oncology: an evidence-based review. Clin Transl Oncol. 2014 Sep;16(9):770-5. doi: 10.1007/s12094-014-1168-8. Epub 2014 Mar 20.
PubMed 24647843Treglia G, Giovannini E, Di Franco D, Calcagni ML, Rufini V, Picchio M, Giordano A. The role of positron emission tomography using carbon-11 and fluorine-18 choline in tumors other than prostate cancer: a systematic review. Ann Nucl Med. 2012 Jul;26(6):451-61. doi: 10.1007/s12149-012-0602-7. Epub 2012 May 8.
PubMed 22566040Kato T, Shinoda J, Nakayama N, Miwa K, Okumura A, Yano H, Yoshimura S, Maruyama T, Muragaki Y, Iwama T. Metabolic assessment of gliomas using 11C-methionine, [18F] fluorodeoxyglucose, and 11C-choline positron-emission tomography. AJNR Am J Neuroradiol. 2008 Jun;29(6):1176-82. doi: 10.3174/ajnr.A1008. Epub 2008 Apr 3.
PubMed 18388218
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-paramEtric Imaging to Assess Treatment REsponse After Stereotactic Radiosurgery of Brain Metastases
- ClinicalTrials.gov ID
- NCT04626206
- Acronym / sponsor ID
- METRE / CCR5331
- Conditions
- Brain Metastases, Adult
- Keywords
- brain metastases, stereotactic radiosurgery, multi-parametric MRI, contrast-clearance analysis MRI, TRAMs, 18F-choline PET/CT, treatment response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Dec 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Differentiating tumour progression/recurrence from radionecrosis post- stereotactic radiosurgery (SRS) of brain metastases can be at times challenging on standard brain MRI. This is because radionecrosis mimics the appearances of tumour progression by appearing as contrast enhancing lesions on standard MRI.The definitive way of differentiating this is surgical excision of the area in question and histopathological evaluation. But this is not always feasible in clinical practice as not all areas of the brain are surgically accessible and an en bloc (complete) resection is needed for the result to be meaningful.
The next best option we have is the multi-parametric MRI which typically consists of three components-MR perfusion, MR diffusion and MR spectroscopy. This investigation is resource intensive, requiring considerable input form MR physics, neuroradiology reporting time , is not routinely available in all centres and hence not viable for routine clinical practice.
Therefore there is an urgent need for a reliable and viable form of imaging modality that helps differentiate tumour from radionecrosis when assessing treatment response post-SRS. It is important to be able to do this accurately as the management of both conditions are entirely different.
Currently the Royal Marsden Hospital is using contrast-clearance analysis MRI (TRAMs) to help differentiate tumour from radionecrosis if the changes seen on standard brain MRI post-SRS are deemed to be unclear. Contrast-clearance analysis MRI (TRAMs) is FDA approved and conforms to European standards (CE marked), yet has sparse evidence on its efficacy. There is some evidence for the use of 18F-choline PET/CT in primary brain tumours (gliomas) but more evidence is needed for its use in brain metastases.
Given that surgical excision is not always feasible for reasons explained above, in this study the investigators consider the muti-parametric MRI as the gold standard investigation for discriminating tumour from radionecrosis.
This pilot brain imaging study is seeking to determine if contrast-clearance analysis MRI (TRAMs) and/or 18F-choline PET/CT are equivalent to multi-parametric MRI in their ability to reliably differentiate between tumour progression/recurrence and radionecrosis. If contrast clearance analysis MRI (TRAMs) and/or 18F-choline PET/CT are found to be equivalent to multi- parametric MRI then it gives the investigators increased confidence in the findings of these readily available imaging modalities, helping treating clinicians to make rapid and reliable management plans- ultimately improving patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Primary outcome will be measured after the last visit of last patient-about 8 months from first recruited patient.
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).
2 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 23717790Stelzer KJ. Epidemiology and prognosis of brain metastases. Surg Neurol Int. 2013 May 2;4(Suppl 4):S192-202. doi: 10.4103/2152-7806.111296. Print 2013.
- Background: PubMed 27939792Lowery FJ, Yu D. Brain metastasis: Unique challenges and open opportunities. Biochim Biophys Acta Rev Cancer. 2017 Jan;1867(1):49-57. doi: 10.1016/j.bbcan.2016.12.001. Epub 2016 Dec 6.
- Background: PubMed 11307056Hoffman JM. New advances in brain tumor imaging. Curr Opin Oncol. 2001 May;13(3):148-53. doi: 10.1097/00001622-200105000-00003.
- Background: PubMed 14970018Hein PA, Eskey CJ, Dunn JF, Hug EB. Diffusion-weighted imaging in the follow-up of treated high-grade gliomas: tumor recurrence versus radiation injury. AJNR Am J Neuroradiol. 2004 Feb;25(2):201-9.
- Background: PubMed 17071335Sundgren PC, Fan X, Weybright P, Welsh RC, Carlos RC, Petrou M, McKeever PE, Chenevert TL. Differentiation of recurrent brain tumor versus radiation injury using diffusion tensor imaging in patients with new contrast-enhancing lesions. Magn Reson Imaging. 2006 Nov;24(9):1131-42. doi: 10.1016/j.mri.2006.07.008. Epub 2006 Sep 18.
- Background: PubMed 19834699Matsusue E, Fink JR, Rockhill JK, Ogawa T, Maravilla KR. Distinction between glioma progression and post-radiation change by combined physiologic MR imaging. Neuroradiology. 2010 Apr;52(4):297-306. doi: 10.1007/s00234-009-0613-9. Epub 2009 Oct 16.
- Background: PubMed 15113465Rock JP, Scarpace L, Hearshen D, Gutierrez J, Fisher JL, Rosenblum M, Mikkelsen T. Associations among magnetic resonance spectroscopy, apparent diffusion coefficients, and image-guided histopathology with special attention to radiation necrosis. Neurosurgery. 2004 May;54(5):1111-7; discussion 1117-9. doi: 10.1227/01.neu.0000119328.56431.a7.
- Background: PubMed 25452395Zach L, Guez D, Last D, Daniels D, Grober Y, Nissim O, Hoffmann C, Nass D, Talianski A, Spiegelmann R, Tsarfaty G, Salomon S, Hadani M, Kanner A, Blumenthal DT, Bukstein F, Yalon M, Zauberman J, Roth J, Shoshan Y, Fridman E, Wygoda M, Limon D, Tzuk T, Cohen ZR, Mardor Y. Delayed contrast extravasation MRI: a new paradigm in neuro-oncology. Neuro Oncol. 2015 Mar;17(3):457-65. doi: 10.1093/neuonc/nou230. Epub 2014 Nov 30.
- Background: PubMed 21362517Chen K, Chen X. Positron emission tomography imaging of cancer biology: current status and future prospects. Semin Oncol. 2011 Feb;38(1):70-86. doi: 10.1053/j.seminoncol.2010.11.005.
- Background: PubMed 17899074Nanni C, Rubello D, Fanti S. Could choline PET play a role in malignancies other than prostate cancer? Eur J Nucl Med Mol Imaging. 2008 Jan;35(1):216-8. doi: 10.1007/s00259-007-0591-2. Epub 2007 Sep 26. No abstract available.
- Background: PubMed 7946521Zeisel SH, Blusztajn JK. Choline and human nutrition. Annu Rev Nutr. 1994;14:269-96. doi: 10.1146/annurev.nu.14.070194.001413.
- Background: PubMed 23010477Fagone P, Jackowski S. Phosphatidylcholine and the CDP-choline cycle. Biochim Biophys Acta. 2013 Mar;1831(3):523-32. doi: 10.1016/j.bbalip.2012.09.009. Epub 2012 Sep 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Welsh, MBBS,FRCR principal investigator
Royal Marsden Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, Adult, run by Royal Marsden NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bharthi Kanagaratnam, MBBS,FRCR (02078082271, Bharthi.kanagaratnam@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Primary outcome will be measured after the last visit of last patient-about 8 months from first recruited patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626206, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.