COMPANY

Lantheus Medical Imaging

HQ: North Billerica, MA source · lantheus.com ↗ · New England

Keywords: neurology Prostate Cancer Alzheimer Disease Coronary Artery Disease Diagnostic Imaging Amyloid Beta-Protein Cardiac Disease Cardiovascular Disease Heart Failure Kawasaki Disease Alzheimer's Disease Relapsed / Refractory Osteosarcoma Clear Cell Renal Cell Carcinoma Metastatic Sarcoma Esophageal Cancer Gastric Cancer Pancreatic Cancer Colorectal Cancer Sarcoma Castration-Resistant Prostatic Cancer Mild Traumatic Brain Injury Heart Disease Pulmonary Heart Disease Brain Cancer Ischemia Nephrogenic Systemic Fibrosis Down Syndrome Liver Disease Ventricular Ejection Fraction Diabetes Type 2 Diabetes Mellitus Coronary Restenosis Myocardial Infarction BMS747158 Florbetaben (BAY94-9172) BAY86-9596 Technetium Tc99m Sestamibi [18F]PI-2620 DEFINITY® DEFINITY

Location: North Billerica, MA · source · Jun 22, 2015

Profile checked Oct 10, 2026

46Trials (company is sponsor)

Timeline

Sep 30, 2026 Trial start Phase 2/Phase 3: Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup]) source ↗
Feb 3, 2026 Trial start Phase 1/Phase 2: Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy) source ↗
2025-11 Trial start Phase 2/Phase 3: Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC source ↗
2025-08 Trial start Phase 1/Phase 2: 64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer source ↗
Feb 8, 2024 Trial start Phase 4: PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer source ↗
May 22, 2023 Trial start —: An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer source ↗
Dec 1, 2022 Trial start 3: [18F]PI-2620 Phase 3 Histopathological Study source ↗
Jun 7, 2021 Trial start Phase 1: Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury source ↗
Dec 28, 2018 Trial start Phase 3: DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY source ↗
Oct 24, 2018 Trial start Phase 3: DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY source ↗
2015-10 Trial start Phase 4: Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD source ↗
2015-05 Trial start Phase 1/Phase 2: PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer source ↗
2014-11 Trial start Phase 1: PET Imaging of Intracranial Cancers With 18F-FSPG source ↗
2013-03 Trial start —: A Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 in Patients Suspected of Coronary Artery Disease (CAD) source ↗
2012-11 Trial start Phase 3: Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI source ↗
2011-06 Trial start 3: A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD. source ↗
2011-05 Trial start Phase 1: PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations source ↗
2011-02 Trial start Phase 1: PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers source ↗
2010-12 Trial start Phase 1: Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer source ↗
2010-11 Trial start Phase 1: 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 source ↗
2010-06 Trial start Phase 1: Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers source ↗
2010-05 Trial start Phase 2: Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing source ↗
2010-05 Trial start Phase 1: 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 Wi source ↗
2010-04 Trial start Phase 1: Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation source ↗
2009-11 Trial start III: Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology source ↗

Showing 25 of 45 dated events.

Upcoming milestones

2027-06 (ESTIMATED) · 3 · [18F]PI-2620 Phase 3 Histopathological Study · NCT05641688
2027-08 (ESTIMATED) · Phase 1/Phase 2 · Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy) · NCT07357519
Sep 30, 2029 (ESTIMATED) · Phase 2/Phase 3 · Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup]) · NCT07831824
2031-02 (ESTIMATED) · · An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer · NCT05712473

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 46

Record	Title	Phase	Status	Start	Primary completion
NCT02681172	Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD	Phase 4	Completed	2015-10	2016-09 (actual)
NCT07831824	Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup])	Phase 2/Phase 3	Recruiting	Sep 30, 2026	Sep 30, 2029 (estimated)
NCT05712473	An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer	Not listed	Active, not recruiting	May 22, 2023	2031-02 (estimated)
NCT05641688	[18F]PI-2620 Phase 3 Histopathological Study	3	Recruiting	Dec 1, 2022	2027-06 (estimated)
NCT07357519	Lu-TARGO (177Lu-TARGeted Osteosarcoma Therapy)	Phase 1/Phase 2	Recruiting	Feb 3, 2026	2027-08 (estimated)
NCT07084909	Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC	Phase 2/Phase 3	Withdrawn	2025-11	2027-09 (estimated)
NCT06074510	PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer	Phase 4	Active, not recruiting	Feb 8, 2024	2026-09 (estimated)
NCT06298916	64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer	Phase 1/Phase 2	Recruiting	2025-08	2025-11 (estimated)
NCT06033001	Expanded Access Treatment with [Lu-177]-PNT2002 for Adult Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)	Not listed	Temporarily not available	Not listed	Not listed
NCT05337774	Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury	Phase 1	Terminated	Jun 7, 2021	Apr 30, 2022 (actual)
NCT00162370	A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease	Phase 4	Completed	2004-04	2012-09 (actual)
NCT03719612	DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY	Phase 3	Completed	Dec 28, 2018	Jan 9, 2020 (actual)
NCT03571672	DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY	Phase 3	Completed	Oct 24, 2018	Aug 30, 2019 (actual)
NCT00918866	A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure	Phase 4	Completed	2009-07	2009-12 (actual)
NCT01347710	A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.	3	Completed	2011-06	2013-07 (actual)
NCT00625365	A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice	IV	Completed	2008-02	2009-05 (actual)
NCT00891241	A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure	1	Completed	2009-08	2009-11 (actual)
NCT00707538	A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress	I	Completed	2008-06	2008-10 (actual)
NCT01299649	Retrospective Safety Study to Compare Mortality in Intensive Care Unite (ICU) Patients Undergoing Echocardiography With or Without DEFINITY®	Not listed	Completed	2008-06	2008-12 (actual)
NCT00707499	A Phase I Study in Healthy Volunteers to Assess Safety of BMS747158	I	Completed	2007-09	2008-05 (actual)
NCT00930631	Study of [3H] BMS747158 in Healthy Male Subjects	Phase 1	Completed	2009-06	2009-07 (actual)
NCT00162032	A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease	Phase 3	Completed	2005-08	2010-05 (actual)
NCT02483884	PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer	Phase 1/Phase 2	Terminated	2015-05	2016-12 (actual)
NCT02370563	PET Imaging of Intracranial Cancers With 18F-FSPG	Phase 1	Terminated	2014-11	2016-03 (actual)
NCT01020838	Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology	III	Completed	2009-11	2011-09 (actual)
NCT00849108	Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158	Phase 2	Completed	2009-01	2010-06 (actual)
NCT01085175	Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing	Phase 2	Withdrawn	2010-05	2011-02 (estimated)
NCT01103310	Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation	Phase 1	Completed	2010-04	2011-08 (actual)
NCT01186601	Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer	Phase 1	Completed	2010-12	2011-10 (actual)
NCT00750282	Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers	II	Completed	2008-08	2010-11 (actual)
NCT01138111	Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients	Phase 1	Completed	2008-06	2011-12 (actual)
NCT01135316	Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR	Not listed	Completed	2009-10	2013-09 (actual)
NCT00928304	Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.	II	Completed	2009-06	2011-01 (actual)
NCT01681524	Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI	Phase 3	Withdrawn	2012-11	2014-02 (estimated)
NCT01085162	A Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 in Patients Suspected of Coronary Artery Disease (CAD)	Not listed	Withdrawn	2013-03	2015-03 (estimated)
NCT01287845	PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers	Phase 1	Completed	2011-02	2011-10 (actual)
NCT01205321	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	Phase 1	Completed	2010-11	2011-11 (actual)
NCT01297088	PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.	Phase 1	Completed	2011-05	2011-12 (actual)
NCT01089998	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	Phase 1	Completed	2010-05	2011-09 (actual)
NCT01153607	Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers	Phase 1	Completed	2010-06	2011-10 (actual)
NCT00162058	A Phase II Study of DMP 115 to Assess Focal Liver Lesions	II	Completed	2004-03	2006-04 (actual)
NCT00162045	A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects	Phase 1/Phase 2	Completed	2005-01	2007-05 (actual)
NCT00401687	DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function	Phase 4	Completed	2006-07	2007-06 (actual)
NCT00162344	A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.	Phase 4	Completed	2003-12	2005-12 (actual)
NCT00162357	Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty	Phase 4	Completed	2004-04	2005-12 (actual)
NCT00162331	CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI	Phase 4	Completed	2005-01	2007-07 (actual)