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Phase 2b Imaging Study of RAD101 for Suspected Recurrent Brain Metastases

This study is testing a new imaging agent called RAD101 (18F-FPIA) to see how well it can identify suspected recurrent brain metastases (cancer that has spread to the brain again). You may be able to join if you are 18 or older and have a history of brain metastases from certain solid tumors like lung, breast, colon, kidney, or melanoma. The study aims to see if RAD101 PET/MRI images match up with standard MRI scans using gadolinium. The study is currently recruiting participants, with a goal of enrolling about 30 people.

Study design
This is a Phase 2b, open-label study involving a single dose of RAD101 in approximately 30 participants.
What's involved
You would have a 4-week screening period, receive a single dose of RAD101, and then have a whole brain PET scan, followed by a 3-day imaging and safety follow-up period.
Compensation
Not stated in the trial record.
Follow-up
After the initial imaging and safety follow-up, data will be collected for up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06777433

Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases

Active, Not Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Radiopharm Theranostics, Ltd
~30 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:RAD101 (18F-FPIA)

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium
Measured over 1 Week
+2 more outcomes measured

Conditions

Brain Metastases From Solid Tumors

Explore related trials

Metastatic Malignant Neoplasm in the BrainSolid Neoplasm

Where it's being run

5 sites across 3 states
Michigan3
Illinois1
Indiana1

Study leadership

  • Dimitris Voliotis, MD · STUDY_DIRECTOR · Radiopharm Theranostics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium1 Week

    Number, size, and proportion of SRS/SRT-treated lesions identified by both RAD101 PET/MRI and MRI (with macrocyclic gadolinium)

  • Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium1 Week

    Number, size, and proportion of SRS/SRT-treated lesions identified by RAD101 PET/MRI and not identified by MRI (with macrocyclic gadolinium)

  • Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium1 Week

    Number, size, and proportion of SRS/SRT-treated lesions not identified by RAD101 PET/MRI and identified by MRI (with macrocyclic gadolinium)