Establishing Radiolabelled PSMA as a Target for Glioma Treatment

NCT05263466 | Not Yet Recruiting

• 1 other identifier: 306945
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma, Malignant

Outcome Measures

Primary Outcomes (1)

• Correlation of the PET-MRI PSMA signal intensity (arbitrary units) and glioma protein concentration (g/L) in a 1 x 1 x 1 cm region of interest (R value)

  PET-MRI signal will be recorded from different regions of interest within a glioma where stereotactic surgical biopsies taken and protein concentration determined.

  5 years

Study Arms (1)

Brain tumour patients

EXPERIMENTAL

Patients will be those undergoing routine care of primary brain tumours. Study group patients will undergo additional PET-MRI examination and biopsies in addition to the standard of care.

Diagnostic Test: PET-MRI; Procedure: Brain tumour biopsy

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 patients

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.

Brain tumour patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College London

London, United Kingdom

Location

Related Publications (4)

• Louis DN, Wesseling P, Aldape K, Brat DJ, Capper D, Cree IA, Eberhart C, Figarella-Branger D, Fouladi M, Fuller GN, Giannini C, Haberler C, Hawkins C, Komori T, Kros JM, Ng HK, Orr BA, Park SH, Paulus W, Perry A, Pietsch T, Reifenberger G, Rosenblum M, Rous B, Sahm F, Sarkar C, Solomon DA, Tabori U, van den Bent MJ, von Deimling A, Weller M, White VA, Ellison DW. cIMPACT-NOW update 6: new entity and diagnostic principle recommendations of the cIMPACT-Utrecht meeting on future CNS tumor classification and grading. Brain Pathol. 2020 Jul;30(4):844-856. doi: 10.1111/bpa.12832. Epub 2020 Apr 19.

  PMID: 32307792 BACKGROUND

• Wernicke AG, Edgar MA, Lavi E, Liu H, Salerno P, Bander NH, Gutin PH. Prostate-specific membrane antigen as a potential novel vascular target for treatment of glioblastoma multiforme. Arch Pathol Lab Med. 2011 Nov;135(11):1486-9. doi: 10.5858/arpa.2010-0740-OA.

  PMID: 22032578 BACKGROUND

• Unterrainer M, Niyazi M, Ruf V, Bartenstein P, Albert NL. The endothelial prostate-specific membrane antigen is highly expressed in gliosarcoma and visualized by [68Ga]-PSMA-11 PET: a theranostic outlook for brain tumor patients? Neuro Oncol. 2017 Nov 29;19(12):1698-1699. doi: 10.1093/neuonc/nox172. No abstract available.

  PMID: 29045711 BACKGROUND

• Abou D, Benabdallah N, Jiang W, Peng L, Zhang H, Villmer A, Longtine MS, Thorek DLJ. Prostate Cancer Theranostics - An Overview. Front Oncol. 2020 Jun 5;10:884. doi: 10.3389/fonc.2020.00884. eCollection 2020.

  PMID: 32582550 BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Thomas C Booth, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas C Booth, PhD

CONTACT

07977509937; thomasbooth@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)