Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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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