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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Aug 2025

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At a glance

  • Drugs RAD 101 (Primary)
  • Indications Brain metastases
  • Focus Diagnostic use; Proof of concept
  • Acronyms RAD101
  • Sponsors Radiopharm Theranostics

Most Recent Events

  • 29 Jul 2025 According to a Radiopharm Theranostics media release, interim Data from the Phase 2b study are expected in the second half of 2025.
  • 11 Jun 2025 According to a Radiopharm Theranostics media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RAD101.
  • 28 Apr 2025 According to a Radiopharm Theranostics media release, company announced the dosing of the first patient in its U.S. Phase 2b imaging study of 18F-RAD101 in suspected recurrent brain metastasis.

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