Clinical Trials
Clinical studies are critical in 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 Title
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer (MIRROR)
Product Candidate
piflufolastat 18F
Disease Area
Prostate Cancer
Status
Recruiting
Phase 4
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.
Study Title
64Cu-LNTH-1363S in Patients with Sarcoma or Gastrointestinal Tract Cancer (PHANTOM)
Product Candidate
64Cu-LNTH-1363S
Disease Area
Sarcoma
Status
Recruiting
Phase 1/2a
This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S.
| Study Name/ID | Study Title | Product Candidate | Disease Area | Status |
|---|---|---|---|---|
(NCT06074510) |
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer (MIRROR) | piflufolastat 18F | Prostate Cancer | Recruiting |
|
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. |
||||
(NCT06298916) |
64Cu-LNTH-1363S in Patients with Sarcoma or Gastrointestinal Tract Cancer (PHANTOM) | 64Cu-LNTH-1363S | Sarcoma | Recruiting |
|
Phase 1/2a |
||||
|
This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S. |
||||
Expanded Access Program
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.