Clinical trials
Clinical studies are critical for the advancement of scientific research and provide us with the opportunity to investigate the impact radiodiagnostics and radiotherapeutics can have on improving patient outcomes.
Every outcome matters
Lantheus is pioneering next-generation radiodiagnostic and radiotherapeutic research in areas of high unmet need.
See below for a list of currently active Lantheus clinical trials. Additional information on all Lantheus-related trials can be found on ClinicalTrials.gov. For more information about clinical trials involving products being developed by Lantheus, please contact our clinical team at clinicaltrials@lantheus.com.
Oncology
| Study Name/ID | Study Title | Product Candidate | Disease Area | Status | |
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(NCT06074510) |
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer (MIRROR) | Study Name/ID: MIRROR (NCT06074510) | Product Candidate: piflufolastat 18F | Disease Area: Prostate cancer | Status: Active, not recruiting |
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Phase: Phase 4 Phase 4 |
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This study is to learn whether piflufolastat 18F imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer. |
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| Study Name/ID | Study Title | Product Candidate | Disease Area | Status | |
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(NCT07357519) |
Phase 1/2, Multi-Center, Open-Label Study Evaluating LNTH-2403, a LRRC15-targeted 177Lutetium-labeled Monoclonal Antibody, in Participants With Relapsed / Refractory Osteosarcoma | Study Name/ID: Lu-TARGO (NCT07357519) | Product Candidate: 177Lu-LNTH-2403 | Disease Area: Relapsed/refractory osteosarcoma | Status: Recruiting |
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Phase: Phase 1/2 Phase 1/2 |
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This is a multi-center, non-randomized, open-label, dosimetry and dose-escalation, cohort-expansion study of LNTH-2403 administered to subjects with relapsed / refractory (R/R) osteosarcoma. This study consists of 2 phases: (1) a dosimetry and dose escalation phase; and (2) a cohort expansion phase. |
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| Study Name/ID | Study Title | Product Candidate | Disease Area | Status | |
|---|---|---|---|---|---|
(NCT06298916) |
64Cu-LNTH-1363S in Patients with Sarcoma or Gastrointestinal Tract Cancer (PHANTOM) | Study Name/ID: PHANTOM (NCT06298916) | Product Candidate: 64Cu-LNTH-1363S | Disease Area: Sarcoma | Status: Recruiting |
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Phase: Phase 1/2A Phase 1/2A |
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This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S. |
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Neurology
| Study Name/ID | Study Title | Product Candidate | Disease Area | Status | |
|---|---|---|---|---|---|
(NCT05641688) |
[18F]PI-2620 Phase 3 Histopathological Study | Study Name/ID: ADvance (NCT05641688) | Product Candidate: LNTH-2620/PI-2620 | Disease Area: Alzheimer’s Disease | Status: Recruiting |
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Phase: Phase 3 Phase 3 |
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ADvance is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with [18F]PI-2620 for detection of tau deposition in subjects with Alzheimer’s disease (AD) and controls during lifetime when compared to histopathology obtained after death and completion of brain autopsy. |
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Cardiology
| Study Name/ID | Study Title | Product Candidate | Disease Area | Status | |
|---|---|---|---|---|---|
(NCT05184088) |
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis (CArdiag) | Study Name/ID: CArdiag (NCT05184088) | Product Candidate: LNTH-2515/Florbetaben | Disease Area: Cardiac AL Amyloidosis | Status: Recruiting |
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Phase: Phase 3 Phase 3 |
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CArdiag is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis. |
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Expanded access program (EAP)
Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow® disease.
Lantheus is focused on conducting clinical trials required by regulatory authorities to thoroughly answer important scientific questions about the potential risks and benefits of our investigational products. A clinical trial is a research program conducted to comprehensively evaluate the safety and effectiveness of an investigational product to treat or diagnose a disease or condition. An investigational product is a product that has not been reviewed or approved by the regulatory authority responsible for determining safety and effectiveness in a particular country.
In the United States, the regulatory authority is the Food and Drug Administration or FDA. The data from clinical trials are provided to a regulatory authority, such as the FDA, to obtain regulatory approval for the investigational product. After receiving regulatory approval, Lantheus can make the product commercially available and healthcare providers (HCPs) can prescribe the product for patients who are most likely to benefit from the product.
