MedTrace Logo

Establishing Radiolabelled PSMA as a Target for Glioma Treatment

NCT05263466 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-06-10

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

PET-MRI

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

PROCEDURE

Brain tumour biopsy

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.

Sponsors & Collaborators

Principal Investigators

  • Thomas C Booth, PhD · King's College London

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2027-05-01
Completion
2027-05-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05263466 on ClinicalTrials.gov