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FDG

Phase 1

Chronic Pain | Small molecule | Pain |GE HealthCare Technologies Inc.|Last Updated: May 16, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03195270Use of PET/MR Imaging in Chronic PainPHASE1 COMPLETED 88Nov 24, 2014Jan 20, 2022May 16, 20231 United States
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Study Endpoints
Primary Endpoints
[18F]FDG PET/MRI as a spatial biomarker for chronic pain
5 years

Identification of structures with increased \[18F\]FDG uptake (SUVmax) corresponding to pain.

Secondary Endpoints
[18F]FDG Biodistribution in Healthy Subjects
5 years
36 point Study Short-Form Health Survey
5 years
Oswestry Disability Index
5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Single ArmEXPERIMENTAL\[18F\]FDG PET/MRI
Interventions
NameTypeDescription
[18F]FDGDRUG10 mCi of \[18F\]FDG via the antecubital vein in a bolus injection
PET/MRIDEVICEPET/MRI hybrid scanner used as diagnostic device
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age 18 years or older. * Chronic pain lasting greater than 2 months. For example: Low back pain, sciatica, complex regional pain syndrome, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, and migraine. * Provides i...

Countries:United States
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