AUS
NZ
UK
CA
USA
FRA
GER
ESP
ITA
NLD
PRT
SWE
GRC
IND
POL
BRA
ZAF
RUS
CHN
UAE
Highlights
- Radiopharm Theranostics initiates Phase 2b trial for brain metastasis imaging.
- 18F-RAD101 targets fatty acid synthase for enhanced diagnostic precision.
- Topline results expected in the second half of 2025.
Radiopharm Theranostics (ASX:RAD) has taken a significant step forward with the dosing of the first patient in its Phase 2b U.S. clinical trial for 18F-RAD101, a novel imaging agent designed to detect suspected recurrent brain metastasis. This pivotal, multicenter, open-label, single-arm study focuses on evaluating the diagnostic performance of 18F-RAD101 among 30 individuals who have been diagnosed with recurrent brain metastases stemming from a variety of solid tumours.
The innovation behind 18F-RAD101 lies in its targeting of fatty acid synthase (FASN), an enzyme often overexpressed in many solid tumour types. By focusing on FASN, 18F-RAD101 provides a unique opportunity to identify cancer cells with high precision. This imaging agent offers the potential to enhance diagnostic accuracy compared to traditional methods, addressing a crucial clinical challenge — distinguishing between true tumour progression and treatment-related changes, a common difficulty with conventional MRI scans.
The primary goal of this Phase 2b study is to assess the concordance between lesions identified using 18F-RAD101 and those detected through standard MRI procedures involving gadolinium. By delivering more reliable imaging outcomes, 18F-RAD101 could revolutionize the way recurrent brain metastases are diagnosed and managed, offering critical support for clinical decision-making.
Speaking about the advancement, Radiopharm Theranostics' Chief Executive Officer and Managing Director, Riccardo Canevari, highlighted the transformative potential of 18F-RAD101. He emphasized that over 300,000 patients are diagnosed annually with brain metastases in the U.S. alone, and more accurate diagnostic tools are urgently needed. The agent’s capability to better differentiate between treatment effects and true tumour progression could significantly impact the clinical pathway for these patients.
The study is expected to conclude with topline results in the second half of 2025. This milestone could pave the way for broader use of 18F-RAD101 in clinical settings, reinforcing Radiopharm Theranostics' (RAD) commitment to developing cutting-edge imaging solutions that address critical gaps in cancer diagnosis and monitoring.
As the trial progresses, further updates are anticipated, offering insights into how this promising technology could reshape brain metastasis imaging practices in the near future.
