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F-18

Phase 1

Neoplasm | Small molecule | Oncology |Bayer AG|Trials Updated: Oct 12, 2022

F-18 target and mechanism

ModalitySmall molecule

Also known as F-18 (BAY85-8050)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

F-18 clinical trials

F-18 · 1 trial · 1 indication

Phase 1 1
NCT00961831Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and PatientsNeoplasm
COMPLETED20 Analytics
PHASE1COMPLETED
Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients
NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual assessment of lesions
Within up to 2 hours after treatment

Secondary Endpoints

Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)
Within up to 2 hours after treatment
Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein
At least 2 times within 8 days after treatment
Electrocardiogram (ECG)
at least 2 times within 8 days after treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
F-18 (BAY85-8050)DRUGCancer patients, injection of BAY 85-8050, PET/CT
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Eligibility Criteria

Age Range35 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers only * Males/females, \>/=50 and \</= 65 years of age * Cancer patients only * Males/females \>/= 35 years and \</= 75 years of age * Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor ma...

Countries:Germany
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Frequently asked questions about F-18

What is F-18 used for?

F-18 is an investigational imaging agent being studied for use in neoplasms, or tumors. It is designed for positron emission tomography and computed tomography, known as PET/CT imaging, to help visualize tumor tissue. It is being developed by Bayer AG and remains in clinical development.

Who makes F-18?

F-18 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the clinical research evaluating the agent in healthy volunteers and patients with neoplasms.

What phase is F-18 in?

F-18 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The agent is investigational and has not been approved for commercial use.

What clinical trials is F-18 in?

F-18 has been evaluated in one completed Phase 1 trial, NCT00961831, titled Radiation Dosimetry, Metabolism, Safety, Tolerability and PET/CT Imaging With BAY 85-8050 in Healthy Volunteers and Patients. The trial enrolled 20 participants in Germany and included healthy volunteers.

Is F-18 the same as BAY85-8050?

Yes, F-18 is also known as BAY85-8050, and the two names refer to the same compound. Bayer AG developed the agent under the BAY85-8050 designation, and it is sometimes written as BAY 85-8050 in trial documentation.