Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [89Zr]DFO-YS5
DFO-YS5 · 1 trial · 12 indications
A volume of interest (VOI) will be placed around each lesion, and the calculated maximum standard uptake value (SUVmax) will be recorded for each lesion. Adjusted SUVmax data will then be averaged across up to 15 lesions within a given patient (SUVmax-avg) at each time point. In order to avoid clustering effects, analyses will be limited to the five largest osseous metastases, five largest lymph node metastases, and five largest visceral/soft tissue metastases. Metastatic lesion location, size (bidimensional axial measurement), and SUVmax will be tabulated. This will be conducted for all lesions.
The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.
The tumor-to-background signal refers to comparing the standardized uptake value (SUV) of a lesion (tumor) to the SUV of a nearby normal organ or tissue that serves as a "background" reference. The ratio of the tumor-to-background signal on PET scan (normal organ as background uptake values) will be calculated as the SUVmax of tumor divided by the SUV of background organ
| Arm | Type | Description |
|---|---|---|
| Treatment ([89Zr]DFO-YS5) | EXPERIMENTAL | Participants will be administered a single, intravenous microdose (1.0 - 3.0 mCi) of \[89Zr\]DFO-YS5, followed by whole-body positron emission tomography (PET) imaging conducted 120-168 hours after \[89Zr\]DFO-YS5 administration (i.e., on Day 6-8). Participants will be followed for treatment-emergent adverse events for up to 35 days. |
| Name | Type | Description |
|---|---|---|
| [89Zr]DFO-YS5 | DRUG | Given intravenously (IV) |
| Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI) | PROCEDURE | Participants may receive a whole-body PET-MRI or a whole body PET-CT |
| Positron Emission Tomography (PET)-Computerized tomography (CT) | PROCEDURE | Participants may receive a whole-body PET-CT or a whole-body PET-MRI |
Inclusion Criteria: 1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm. 2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography ...
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