Genesis GBM 001 Phase I/II study of 68Ga-PSMA as a tumour targeting agent in relapsed glioblastoma

Not Applicable

Completed

• Conditions: Brain CancerGlioblastoma; Brain Cancer; Glioblastoma; Cancer - Brain

• Registration Number: ACTRN12618001346268
• Lead Sponsor: Genesis Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-09
• Study Completion: 2021-09-13
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

•Previously histologically confirmed glioblastoma at resection
•Progression noted on pre-enrolment MRI scan
•Aged 18 years or older
•An ECOG performance status score of 2 or less (see appendices)
•Participants capable of childbearing are using adequate contraception
•Available for scanning on 2 separate days
•Has provided written Informed Consent for participation in this trial once eligibility is meet

Exclusion Criteria

•Women who are pregnant or lactating.
•Geographically remote from the treating centre which would not allow multiple presentation for imaging

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the uptake in relapsed glioblastoma of Ga-68 PSMA on PET scans. <br>This will be done by quantitatively measuring the tumour volume and PSMA receptor activity, FET and PMSA tracer concentrations will be normalized to the injected dose per kilogram of patient’s body weight to generate standardized uptake values (SUVs). The tumour volume will be manually defined by an experienced PET physician from the FET images.<br>This is not separate primary outcomes.[12 months post accrual of cohort.]

Secondary Outcome Measures

Name	Time	Method
To investigate the feasibility of undertaking PET theranostic research.<br>This analysis will determine whether a clinical trial using a therapeutic dose of 177Lu-PSMA would be feasible for these patients.<br>The decision to go on to a therapy study will depend on the standard uptake value (SUV) of PSMA PET. If this is high (great than 3) its likely that this will be feasible. <br>The percentage of patients showing uptake would also impact on feasibility.[Within 12 months of patient recruitment completetion]