Clinical trial · NCT05263466 · NOT_YET_RECRUITING · NA
Establishing Radiolabelled PSMA as a Target for Glioma Treatment
Sponsor: King's College Hospital NHS Trust
Summary
A study is being performed to observe whether a novel type of brain imaging using a technique called PET-MRI may provide useful information in the 'mapping' of adult primary brain tumours. It employs a radiolabelled molecule targeting a particular molecule called PSMA which is hypothesised to be a marker of aggression in primary brain tumours. 'Mapping' of the concentration and distribution of this molecule within brain tumours via PET-MRI may provide vital clinical information regarding the extent and timing of treatment.
Interventions
- PET-MRI · DIAGNOSTIC_TEST
For the diagnostic imaging aspect included in this pilot study, \[68Ga\]PSMA-11 will be used. This is a peptidomimetic agent with a covalently bound chelator (HBED-CC) that is FDA-approved in prostate cancer imaging. We will use PET-MRI to visualise a) the concentration and b) the distribution of this tracer to establish a functional map of primary brain tumour activity
- Brain tumour biopsy · PROCEDURE
All patients included in our study will undergo stereotactic surgery for biopsy/resection of the tumour as part of the standard of care at KCH. During this study we will not vary from the surgical standard of care for primary brain tumours and will only extend the surgery time due to additional stereotactic biopsies (an additional 3 biopsies increasing the time of the operation by \~30 minutes). Professor Ashkan (KCH) has defined the additional surgical risk of performing these biopsies to be \~0%, since targeted biopsies will only be taken within the tumour just before resection. The stereotactic biopsy may be targeted to areas of high \[68Ga\]PSMA SUV within the tumour as defined by the PET MRI scan.
Published eligibility criteria
Verbatim from the registry. Only the site can decide how these apply to a specific patient.
Inclusion Criteria: * Individuals of 18 years or older * Referred for surgery (resection or biopsy) of presumed high grade primary brain tumour (based on imaging features of aggression e.g. perfusion imaging, diffusion restriction etc.). As standard, all patients will have had a full body CT and other investigations to rule out metastatic disease (this has a very high negative predictive value). * Written informed consent Exclusion Criteria: * Patient already enrolled in a drug trial * Contra-indication for MRI contrast * Contra-indication for radiotracer * Inability to give consent * Patient is pregnant or planning to become pregnant
Sites (1)
- King's College London, London, United Kingdom
Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2022-06-10.