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PET tracer

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

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
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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
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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
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Frequently asked questions about PET tracer

What is the PET tracer used for?

The PET tracer is an investigational small molecule being studied for use in oncology, specifically for imaging neoplasms, or tumors. It is being developed as a diagnostic imaging agent to explore tumor accumulation in patients with cancer. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does the PET tracer target?

The PET tracer is a small molecule designed for positron emission tomography imaging in oncology. While its specific molecular target is not disclosed, it is intended to accumulate in tumors, allowing visualization of neoplasms. This mechanism enables detection and characterization of cancerous lesions in patients undergoing imaging procedures.

Who makes the PET tracer?

The PET tracer is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. Lantheus is responsible for the clinical development of this investigational imaging agent, which is currently in Phase 1 trials for use in patients with neoplasms.

What phase is the PET tracer in?

The PET tracer is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized study that enrolled 30 participants. The drug remains investigational and has not received FDA approval, as it is still in the early stages of clinical evaluation for oncology imaging.

What clinical trials is the PET tracer in?

The PET tracer has been studied in one clinical trial, identified as NCT01186601, titled "Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer." This Phase 1 study was completed in the United States and enrolled 30 adult participants with neoplasms. The trial was uncontrolled and did not use randomization or blinding.

Is the PET tracer the same as BAY94-9392?

Yes, the PET tracer is also known as BAY94-9392, as indicated by the clinical trial title for study NCT01186601. This alternative name was used in the Phase 1 trial that explored tumor accumulation of the agent in patients with cancer. Both names refer to the same investigational imaging compound.