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BAY86-9596

Phase 1

Diagnostic Imaging | Small molecule | Other |Lantheus Holdings, Inc.|Last Updated: Jan 21, 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

BAY86-9596 · 2 trials · 1 indication

Phase 1 2
NCT01297088PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.Diagnostic Imaging
COMPLETED24 Analytics
NCT01089998PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With InflammationsDiagnostic Imaging
COMPLETED35 Analytics
PHASE1COMPLETED
PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.
Diagnostic ImagingUnlock trial analytics
PHASE1COMPLETED
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations
Diagnostic ImagingUnlock trial analytics

Study Endpoints

Primary Endpoints

BAY86-9596 lesion detection rate (overall number of lesions identified).
up to 2 hours
Overall image quality (poor, satisfactory, excellent; based on investigator's experience with 18F-labeled PET tracers)
up to 2 hours
BAY86-9596 accumulation score in identified lesions (low accumulation, high accumulation).
up to 2 hours
Comparative score BAY86-9596 versus FDG. If an FDG PET/CT is not available (in malignant brain tumors or in brain metastasis), this comparison will be done with routine imaging modalities such as CT or MRI, or choline PET/CT.
up to 2 hours
Comparison of BAY86-9596 accumulation with lesions identified in histology of prostate cancer.
up to 2 hours
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
Day of study drug administration

Secondary Endpoints

Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)
Day of study drug administration
Vital signs (ECG, blood pressure, Heart rate, Body temperature)
At least 2 times within 8 days after treatment
Serum chemistry, Clotting status, Hematology
At least 2 times within 8 days after treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Arm 4EXPERIMENTAL -

Interventions

NameTypeDescription
BAY86-9596DRUGOne single dose administration of a diagnostic agent
Fludeoxyglucose (18F)-IBADRUGSubgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)
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Eligibility Criteria

Age Range30 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Cancer Patients * Patient had an Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computer tomography(CT) performed 14 days prior to treatment with BAY86-9596 for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass wit...

Countries:SingaporeNetherlandsSwitzerland
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Competitive Landscape -Diagnostic and Imaging 9 trials (matched to "Diagnostic Imaging")

Frequently asked questions about BAY86-9596

What is BAY86-9596 used for?

BAY86-9596 is an investigational diagnostic imaging agent being developed for use in positron emission tomography (PET) and computed tomography (CT) imaging. It is being studied to evaluate its safety, tolerability, and diagnostic performance in patients with non-small cell lung cancer, breast cancer, head and neck cancer, and inflammations.

What does BAY86-9596 target?

BAY86-9596 is a small molecule used as a PET/CT imaging agent. It is designed to be administered intravenously and detected by PET/CT imaging to help visualize cancer and inflammatory conditions. The specific molecular target of BAY86-9596 has not been disclosed in the available clinical trial information.

Who makes BAY86-9596?

BAY86-9596 is being developed by Lantheus Holdings, Inc. (ticker: LNTH). The company is conducting clinical trials to evaluate the imaging agent's safety, tolerability, and diagnostic performance in patients with certain cancers and inflammations.

What phase is BAY86-9596 in?

BAY86-9596 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 59 participants enrolled. The drug is investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is BAY86-9596 in?

BAY86-9596 has been studied in two completed Phase 1 trials. NCT01089998 enrolled 35 participants in the Netherlands and Switzerland to assess radiation dosimetry, pharmacokinetics, safety, and diagnostic performance in healthy volunteers and patients with certain cancers or inflammations. NCT01297088 enrolled 24 participants in Singapore to evaluate PET/CT imaging after a single intravenous dose in patients with cancer or inflammations.

Is BAY86-9596 the same as 18F-BAY86-9596?

BAY86-9596 is a fluorine-18 labeled compound, as indicated by the trial title referencing BAY86-9596 (18F). It is administered as a single intravenous dose for PET/CT imaging. The drug is also referred to as BAY86-9596 (18F) in clinical trial documentation.