Approval Probability
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Adjusted LOA
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Ga DOTA · 1 trial · 1 indication
To assess the ability of \[68Ga\]Ga DOTA-5G to detect lesions: detection of metastasis by \[68Ga\]Ga DOTA-5G , positive vs. negative based on if SUVmax above background brain, bone, lung, or liver of \[68Ga\]Ga DOTA-5G in at least one lesion assessed by \[68Ga\]Ga DOTA-5G PET/CT and identified on \[18F\]-FDG PET/CT diagnostic imaging.
| Arm | Type | Description |
|---|---|---|
| [68Ga]Ga DOTA-5G PET/CT imaging | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [68Ga]Ga DOTA-5G | DRUG | Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection |
Inclusion Criteria: * Ability to understand and willingness to sign a written informed consent document. * Men and women age ≥ 18 yrs * Confirmed presence of metastatic breast cancer * Eastern Cooperative Oncology Group Performance Status ≤ 2 * Hematologic parameters defined as: * Absolute neutroph...
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