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RAD101

Phase 2

Brain Metastases From Solid Tumors | Small molecule | Oncology |Medpace Holdings, Inc. Common Stock|Last Updated: Aug 12, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

RAD101 · 1 trial · 1 indication

Phase 2 1
NCT06777433Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain MetastasesBrain Metastases From Solid Tumors
ACTIVE NOT_RECRUITING30 Analytics
PHASE2ACTIVE NOT_RECRUITING
Phase 2b Imaging Study of RAD101 in Participants With Suspected Recurrent Brain Metastases
Brain Metastases From Solid Tumors
NCT0677743330
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Study Endpoints

Primary Endpoints

Concordance between RAD101 PET/MRI and MRI with macrocyclic gadolinium
1 Week

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

Secondary Endpoints

Accuracy of RAD101 in identifying tumor recurrence versus radiation necrosis in previously SRS-treated brain metastasis
6 months
Safety and tolerability of a single dose of RAD101
48 Hours
Optimal dose of RAD101
1 week
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
RAD101 (18F-Fluorescence polarization immunoassay (FPIA))EXPERIMENTAL370 MBq (10 mCi) single dose administered at Day 1 visit

Interventions

NameTypeDescription
RAD101 (18F-FPIA)DRUGA single dose of 18F-RAD101 with a maximum of 370 MBq (10 mCi) administered as a slow IV bolus injection over a maximum of 30 seconds, followed by a saline flush.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Must be ≥ 18 years of age at the time of signing the informed consent. 2. Participant has one of the following histopathologically confirmed advanced solid tumors with known history of brain metastases: lung, breast, colon, kidney, or melanoma, and with known history of brain...

Countries:United States
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