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Also known as [68Ga]-LNTH-2401
LNTH-2401 · 1 trial · 1 indication
Image quality scores (IQS) for administered activity (radioactivity) for \[68Ga\]-LNTH-2401 PET/CT
Image quality scores (IQS) for imaging time windows for \[68Ga\]-LNTH-2401 PET/CT
Time activity curves (TACs), describing the percentage of the injected activity versus time will be derived for standard organs. Absorbed radiation doses of \[68Ga\]-LNTH-2401in standard organs; whole-body effective dose will also be estimated.
Frequency and severity of AEs per CTCAE version 6.0 for \[68Ga\]-LNTH-2401.
Co-primary endpoints of: Participant-level specificity (TN/\[TN + FP\]) of \[68Ga\]-LNTH-2401 PET/CT for detection of prostate cancer in pelvic lymph nodes relative to histopathology. Participant-level sensitivity (TP/\[TP + FN\]) of \[68Ga\]-LNTH-2401 PET/CT for detection of prostate cancer in pelvic lymph nodes relative to histopathology.
| Arm | Type | Description |
|---|---|---|
| [68Ga]-LNTH-2401 | EXPERIMENTAL | Phase 2 period, \[68Ga\]-LNTH-2401 will be administered at 5 (±1) mCi (148 to 222 MBq). Phase 3 period, the intended commercial-use manufactured \[68Ga\]-LNTH 2401 product will be administered for imaging at the optimized dose selected from the Phase 2 period. |
| Name | Type | Description |
|---|---|---|
| [68Ga]-LNTH-2401 | DRUG | \[68Ga\]-LNTH-2401 will be administered to identify newly diagnosed prostate cancer. |
Inclusion Criteria: Participants must meet all of the criteria below as defined to be enrolled in the study. 1. Participants must be male and ≥18 years old or defined as adults per applicable local laws and regulations, at the time of signing the informed consent. 2. Participants who are sexually ...
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LNTH-2401 is an investigational small molecule imaging agent being developed for prostate cancer. It is also known as [68Ga]-LNTH-2401. Lantheus Holdings, Inc. is running a Phase 2/3 study of the agent in prostate cancer staging and diagnostic performance, with enrollment of 408 participants.
LNTH-2401 is being studied for use in prostate cancer, specifically in staging and diagnostic workup. Its Phase 2/3 trial, called SPARROW (Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup), evaluates dose optimization and diagnostic performance in men with prostate cancer.
LNTH-2401 is being developed by Lantheus Holdings, Inc., which trades under the ticker LNTH. Lantheus is the sponsor of the SPARROW trial evaluating the agent in prostate cancer.
LNTH-2401 is in Phase 2/3 clinical development. It is investigational and is being evaluated in a single recruiting study, the SPARROW trial, which has an estimated enrollment of 408 participants.
LNTH-2401 is being studied in the SPARROW trial, registered as NCT07831824. The Phase 2/3 study is recruiting men aged 18 years and older with prostate cancer in the United States. It is an uncontrolled trial with an estimated enrollment of 408 participants and focuses on dose optimization and diagnostic performance.
Yes, [68Ga]-LNTH-2401 is another name for LNTH-2401. The two names refer to the same Lantheus Holdings investigational agent being studied in prostate cancer under the SPARROW Phase 2/3 trial, NCT07831824.