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F-18

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

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 small molecule being studied for use in oncology, specifically for imaging in patients with neoplasms. It is a positron emission tomography/computed tomography (PET/CT) imaging agent. F-18 is currently in Phase 1 clinical development and is not approved by the FDA.

Who makes F-18?

F-18 is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 1 clinical development for oncology imaging applications.

What phase is F-18 in?

F-18 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for use in positron emission tomography/computed tomography (PET/CT) imaging in patients with neoplasms.

What clinical trials is F-18 in?

F-18 has one completed Phase 1 clinical trial, NCT00961831, which evaluated radiation dosimetry, metabolism, safety, tolerability, and PET/CT imaging with BAY 85-8050 in healthy volunteers and patients with neoplasms. The trial enrolled 20 participants in Germany.

Is F-18 the same as BAY 85-8050?

Yes, F-18 is also known as BAY 85-8050. The clinical trial NCT00961831 evaluated the safety, tolerability, and imaging properties of BAY 85-8050, which is the same investigational drug referred to as F-18.