Recent Updates
Recently added Catalysts

PET tracer

Phase 1

Neoplasms | Small molecule | Oncology |Lantheus Holdings, Inc.|Trials Updated: Nov 13, 2014

PET tracer target and mechanism

ModalitySmall molecule

Also known as PET tracer (BAY94-9392)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

PET tracer clinical trials

PET tracer · 1 trial · 1 indication

Phase 1 1
NCT01186601Exploration of Tumor Accumulation of BAY94-9392 in Patients With CancerNeoplasms
COMPLETED30 Analytics
PHASE1COMPLETED
Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
Day 1
Evaluation of the accumulation of BAY94-9392 in known or suspected local and/or systemic recurrent cancer lesions and/or lymph node metastasis or distant metastasis.
Day 1

Secondary Endpoints

Standardized uptake value (SUV)
Day 1
Standardized uptake value ratio (SUVR)
Day 1
Vital Signs
Day 1 and Day 2
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
PET tracer (BAY94-9392)DRUGA radioactive dose of 300 MBq of the study drug with a total quantity of \</= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males/females \>/= 18 years * Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis ar...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about PET tracer

What is the PET tracer (BAY94-9392)?

The PET tracer (BAY94-9392) is an investigational small molecule imaging agent being developed by Lantheus Holdings, Inc. for use in oncology. It is designed to be used as a positron emission tomography tracer to explore tumor accumulation in patients with cancer. It is currently in Phase 1 clinical development.

What is the PET tracer (BAY94-9392) used for in neoplasms?

The PET tracer (BAY94-9392) is being studied for imaging in patients with neoplasms, specifically to explore tumor accumulation in cancer patients. It is an oncology imaging agent in Phase 1 development and has been evaluated in a single completed clinical trial in the United States.

Who makes the PET tracer (BAY94-9392)?

The PET tracer (BAY94-9392) is being developed by Lantheus Holdings, Inc., which trades on the Nasdaq under the ticker symbol LNTH. Lantheus is the sponsor of the clinical development program for this oncology imaging agent.

What phase is the PET tracer (BAY94-9392) in?

The PET tracer (BAY94-9392) is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this agent.

What clinical trials is the PET tracer (BAY94-9392) in?

The PET tracer (BAY94-9392) has been studied in one completed Phase 1 trial, NCT01186601, titled Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer. The trial enrolled 30 patients with neoplasms in the United States and has completed.

Is the PET tracer the same as BAY94-9392?

Yes, the PET tracer is also known as BAY94-9392. BAY94-9392 is an alternative designation for the same investigational oncology imaging agent being developed by Lantheus Holdings, Inc. under the ticker LNTH.