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Bombesin labeled

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

RandomizedCONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Bombesin labeled · 1 trial · 1 indication

Phase 1 1
NCT01205321PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy VolunteersDiagnostic Imaging
COMPLETED19 Analytics
PHASE1COMPLETED
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
Diagnostic ImagingUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual assessment of lesions
Day of study drug administration

Secondary Endpoints

Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)
Day of study drug administration
ECG (significant abnormalities)
At least 3 times until one day after treatment
Blood pressure
At least 3 times until one day after treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
Bombesin (68Ga) labeled (BAY86-7548)DRUGCancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
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Eligibility Criteria

Age Range45 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Healthy volunteers: * males, \>/=50 and \</= 65 years of age * Cancer patients: * males \>/= 45 years of age * Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary ...

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

Frequently asked questions about Bombesin labeled

What is Bombesin labeled used for?

Bombesin labeled is an investigational small molecule being studied for use in diagnostic imaging. It is being evaluated as a PET/CT imaging agent for radiation dosimetry, plasma pharmacokinetics, biodistribution, safety, tolerability, and diagnostic performance in patients with prostate cancer and healthy volunteers.

Who makes Bombesin labeled?

Bombesin labeled is being developed by Lantheus Holdings, Inc., which trades under the ticker LNTH. The company is conducting clinical research on this diagnostic imaging agent.

What phase is Bombesin labeled in?

Bombesin labeled is in Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. The Phase 1 trial has been completed.

What clinical trials is Bombesin labeled in?

Bombesin labeled has one completed Phase 1 trial, NCT01205321, which evaluated PET/CT imaging for radiation dosimetry, plasma pharmacokinetics, biodistribution, safety, tolerability, and diagnostic performance in patients with prostate cancer and healthy volunteers. The trial enrolled 19 participants.

Is Bombesin labeled the same as BAY86-7548?

Yes, Bombesin labeled is also known as BAY86-7548. The clinical trial NCT01205321 used the name BAY86-7548 to refer to this investigational diagnostic imaging agent.