New Clinical Trial Data Highlights RAD 101 (18F-Pivalate) Successfully Detects Brain Metastases
Radiopharm Theranostics (NASDAQ: RADX) has announced successful clinical trial results for RAD 101 (18F-Pivalate) in detecting brain metastases. The study, published in the European Journal of Nuclear Medicine and Molecular Imaging, demonstrated effective detection using a novel hybrid imaging approach combining PET and Multiparametric MRI.
The trial included 22 patients (12 treatment-naïve and 10 previously treated with brain radiation), showing successful detection of brain metastases regardless of tumor origin, with high tumor-to-background ratio. RAD 101, targeting fatty acid metabolism in solid tumors, has shown promising results in detecting cerebral metastases.
The company is currently conducting a Phase 2b clinical trial in the United States to evaluate RAD 101's diagnostic performance in patients with suspected recurrent brain metastases from solid tumors. This advancement could potentially improve upon current standard-of-care Contrast Enhanced MRI, which has sensitivity in distinguishing disease progression from radiotherapy effects.
Radiopharm Theranostics (NASDAQ: RADX) ha annunciato risultati positivi di uno studio clinico per RAD 101 (18F-Pivalate) nella rilevazione delle metastasi cerebrali. Lo studio, pubblicato nell'European Journal of Nuclear Medicine and Molecular Imaging, ha dimostrato un'efficace rilevazione utilizzando un innovativo approccio di imaging ibrido che combina PET e risonanza magnetica multiparametrica.
Il trial ha incluso 22 pazienti (12 mai trattati e 10 precedentemente trattati con radioterapia al cervello), mostrando una rilevazione efficace delle metastasi cerebrali indipendentemente dall'origine tumorale, con un elevato rapporto tumore-sfondo. RAD 101, che mira al metabolismo degli acidi grassi nei tumori solidi, ha mostrato risultati promettenti nella rilevazione delle metastasi cerebrali.
L'azienda sta attualmente conducendo un trial clinico di Fase 2b negli Stati Uniti per valutare le prestazioni diagnostiche di RAD 101 in pazienti con sospette metastasi cerebrali ricorrenti da tumori solidi. Questo progresso potrebbe migliorare gli attuali standard di cura rappresentati dalla risonanza magnetica con contrasto, che ha una sensibilità nel distinguere la progressione della malattia dagli effetti della radioterapia.
Radiopharm Theranostics (NASDAQ: RADX) ha anunciado resultados exitosos de ensayos clínicos para RAD 101 (18F-Pivalato) en la detección de metástasis cerebrales. El estudio, publicado en el European Journal of Nuclear Medicine and Molecular Imaging, demostró una detección efectiva utilizando un enfoque de imagen híbrido novedoso que combina PET y Resonancia Magnética Multiparamétrica.
El trial incluyó 22 pacientes (12 nunca tratados y 10 tratados previamente con radioterapia cerebral), mostrando una detección exitosa de metástasis cerebrales independientemente del origen tumoral, con una alta relación tumoral-fondo. RAD 101, que se enfoca en el metabolismo de ácidos grasos en tumores sólidos, ha mostrado resultados prometedores en la detección de metástasis cerebrales.
La empresa está llevando a cabo actualmente un ensayo clínico de Fase 2b en los Estados Unidos para evaluar el rendimiento diagnóstico de RAD 101 en pacientes con metástasis cerebrales recurrentes sospechosas provenientes de tumores sólidos. Este avance podría mejorar la actual resonancia magnética con contraste, que tiene sensibilidad para distinguir la progresión de la enfermedad de los efectos de la radioterapia.
Radiopharm Theranostics (NASDAQ: RADX)는 뇌 전이 탐지에 대한 RAD 101 (18F-Pivalate)의 임상 시험 결과가 성공적이라고 발표했습니다. 유럽 핵의학 및 분자영상 저널에 발표된 이 연구는 PET와 다중 매개변수 MRI를 결합한 새로운 하이브리드 이미징 접근 방식을 사용하여 효과적으로 탐지할 수 있음을 보여주었습니다.
이 시험에는 22명의 환자가 포함되었으며 (12명의 치료 경험이 없는 환자와 10명의 뇌 방사선 치료를 받은 환자), 종양 기원에 관계없이 높은 종양-배경 비율로 뇌 전이를 성공적으로 탐지했습니다. 고형 종양에서 지방산 대사를 표적으로 하는 RAD 101은 뇌 전이를 탐지하는 데 유망한 결과를 보였습니다.
회사는 현재 미국에서 2b상 임상 시험을 실시하여 고형 종양에서 의심되는 재발성 뇌 전이를 가진 환자에서 RAD 101의 진단 성능을 평가하고 있습니다. 이 발전은 방사선 요법의 효과와 질병 진행을 구별하는 데 민감성을 가진 현재의 표준 치료인 대비 MRI를 개선할 수 있습니다.
Radiopharm Theranostics (NASDAQ: RADX) a annoncé des résultats réussis d'essais cliniques pour RAD 101 (18F-Pivalate) dans la détection des métastases cérébrales. L'étude, publiée dans l'European Journal of Nuclear Medicine and Molecular Imaging, a montré une détection efficace en utilisant une nouvelle approche d'imagerie hybride combinant PET et IRM multiparamétrique.
L'essai a inclus 22 patients (12 non traités et 10 ayant déjà été traités par radiothérapie cérébrale), montrant une détection réussie des métastases cérébrales indépendamment de l'origine tumorale, avec un rapport élevé tumeur-fond. RAD 101, ciblant le métabolisme des acides gras dans les tumeurs solides, a montré des résultats prometteurs dans la détection des métastases cérébrales.
L'entreprise effectue actuellement un essai clinique de phase 2b aux États-Unis pour évaluer la performance diagnostique de RAD 101 chez des patients suspectés de métastases cérébrales récurrentes provenant de tumeurs solides. Cette avancée pourrait potentiellement améliorer les standards de soins actuels représentés par l'IRM avec contraste, qui possède une sensibilité dans la distinction entre la progression de la maladie et les effets de la radiothérapie.
Radiopharm Theranostics (NASDAQ: RADX) hat positive Ergebnisse klinischer Studien für RAD 101 (18F-Pivalat) bei der Detektion von Hirnmetastasen bekannt gegeben. Die Studie, veröffentlicht im European Journal of Nuclear Medicine and Molecular Imaging, zeigte eine effektive Erkennung durch einen neuartigen hybriden Bildgebungsansatz, der PET und multiparametrische MRT kombiniert.
Die Studie umfasste 22 Patienten (12 zuvor nicht behandelte und 10, die zuvor mit Strahlentherapie behandelt wurden) und zeigte eine erfolgreiche Erkennung von Hirnmetastasen unabhängig von der Tumorursache mit einem hohen Tumor-Hintergrund-Verhältnis. RAD 101, das den Fettsäuremetabolismus in soliden Tumoren angreift, hat vielversprechende Ergebnisse bei der Erkennung zerebraler Metastasen gezeigt.
Das Unternehmen führt derzeit eine Phase 2b-Studie in den Vereinigten Staaten durch, um die diagnostische Leistung von RAD 101 bei Patienten mit Verdacht auf wiederkehrende Hirnmetastasen aus soliden Tumoren zu bewerten. Dieser Fortschritt könnte die aktuellen Standardverfahren wie die kontrastverstärkte MRT verbessern, die eine Sensitivität aufweist, um Krankheitsprogression von den Effekten der Strahlentherapie zu unterscheiden.
- Successful detection of brain metastases in all 22 trial patients
- High tumor-to-background ratio achieved in imaging results
- Effective detection regardless of prior treatment status or tumor origin
- Phase 2b trial actively recruiting in the United States
- None.
Insights
The latest clinical trial results for RAD 101 represent a significant breakthrough in brain metastasis detection technology. The study's success across 22 patients demonstrates exceptional versatility in detecting metastases regardless of prior treatment status or primary tumor origin - a important advantage in clinical settings.
Key technical achievements include the novel combination of PET-mpMRI imaging methodology, which addresses a critical limitation in current diagnostic procedures. Standard Contrast Enhanced MRI often struggles to differentiate between disease progression and radiation treatment effects, leading to diagnostic uncertainty and potential treatment delays. RAD 101's ability to maintain high tumor-to-background ratio across different scenarios suggests superior diagnostic clarity.
The mechanism targeting fatty acid metabolism represents an innovative approach, as cancer cells are known to have altered metabolic profiles. This metabolic targeting strategy could prove particularly valuable for detecting brain metastases, which occur four times more frequently than primary brain tumors.
The ongoing Phase 2b trial in the United States marks a critical step toward potential commercialization. With brain metastases becoming more prevalent due to improved cancer treatments extending patient survival, the market need for more accurate diagnostic tools is growing. RAD 101's demonstrated capabilities could position Radiopharm as a leader in this expanding market segment.
From a technical perspective, the successful integration of 18F-RAD101 with PET-mpMRI suggests potential cost-effectiveness through improved diagnostic accuracy, potentially reducing the need for multiple follow-up scans or invasive procedures. This could translate to significant healthcare cost savings while improving patient care outcomes.
- Successful detection of brain metastases using RAD 101 (18F-Pivalate) in a novel multiparametric imaging methodology (PET-mpMRI) study across 22 patients.
- All brain metastases, regardless of whether they were previously treated with radiation and the tumor of origin, were detected with RAD101, demonstrating a high tumor-to-background ratio.
- A Phase 2b imaging study to evaluate the diagnostic performance of RAD 101 in individuals with suspected recurrent brain metastases is currently recruiting in the United States.
SYDNEY, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, NASDAQ: RADX “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the publication of a novel imaging approach demonstrating proof-of-concept for the use of RAD 101 for successful detection of brain metastases (both treatment-naïve and previously treated) from a variety of primary solid tumors.
The clinical study, recently published by Islam et al. in the prestigious European Journal of Nuclear Medicine and Molecular Imaging1, reports a novel methodology of detecting brain metastases using the proprietary radiotracer 18F-RAD101 in a hybrid imaging test that combines Positron Emission Tomography and Multiparametric Magnetic Resonance Imaging (PET-mpMRI). The study investigated the imaging characteristics of brain metastases in 12 treatment-naïve (no prior brain radiotherapy) patients and 10 patients who had previously been treated with brain radiation2. All brain metastases, regardless of the tumor of origin, were detected with 18F-RAD101 PET-mpMRI, with a high tumor-to-background ratio.
RAD 101 is a novel imaging small molecule that targets fatty acid metabolism, which is upregulated in many solid tumors, including cerebral metastases. Targeting the transport and metabolism of fatty acid synthase, RAD 101 enables accurate detection of cancer cells, representing a viable target for the imaging of brain metastases. In October 2022, preliminary positive data from the Imperial College of London’s Phase 2a imaging trial of RAD 101 in patients with brain metastases showed significant tumor uptake that was independent from the tumor of origin3, now confirmed in the larger study.
Radiopharm’s RAD 101 Phase 2b clinical trial, entitled “An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron Emission Tomography (PET) in Participants with Suspected Recurrent Brain Metastases from Solid Tumors”, is currently open and recruiting in the United States4. The trial is designed to evaluate the diagnostic performance of 18F-RAD101 in individuals with suspected recurrent brain metastasis from solid tumors of different origins.
“Intracranial metastases occur with a frequency four-times higher than primary tumors of the brain,” said Dr Eric Aboagye, lead inventor of RAD 101, co-author of the publication, Professor of Cancer Pharmacology & Molecular Imaging at the Imperial College of London, and Director of the CRUK-EPSRC-MRC-NIHR Comprehensive Cancer Imaging Centre. “With a poor prognosis, there is a need for improved detection and characterization of these metastases. Our work affirms the current understanding of the way in which cancers of diverse origin utilise simple short chain fatty acids compared to glucose and other nutrients in the brain environment, and how to employ this information to improve detection of metastases in the brain. 18F-RAD101 PET also provides us with opportunities to delve deeply into therapeutic opportunities.”
“The rising incidence of brain metastases is largely attributed to improved systemic cancer treatments leading to longer patient survival,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “Contrast Enhanced MRI is the current standard of care but provides limited sensitivity for distinguishing disease progression from radiotherapy versus treatment effects. This is the first clinical study with 18F-RAD101 PET-mpMRI that demonstrates potentially more sensitive detection of brain metastases compared to current standard of care, offering a strong potential to improve diagnostic accuracy of suspected recurrent brain metastases.”
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021 and on the Nasdaq (RADX) since November 2024. The company has a deep pipeline of highly differentiated molecules spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development. The pipeline has been built based on the potential to be first-to-market or best-in-class. The clinical program includes one Phase II and three Phase I trials in a variety of solid tumour cancers including brain, lung, breast and pancreas. Learn more at radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
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1 Islam, S., Inglese, M., Aravind, P. et al. A hybrid [18F]fluoropivalate PET-multiparametric MRI to detect and characterise brain tumour metastases based on a permissive environment for monocarboxylate transport. Eur J Nucl Med Mol Imaging (2025). https://doi.org/10.1007/s00259-025-07118-0
2 NCT04807582
3 Poster Presentation - 34th EORTC/AACR/NCI Annual Symposium, Barcelona, Spain, 26-28th October 2022
4 NCT06777433
FAQ
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