רדאר ניסויים קליניים

Compare pre-therapy and post-therapy voxel-based dosimetry estimates

Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated.

Baseline and 120 hours post-dose

Absorbed radiation doses

Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics.

1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose

Absorbed radiation doses of 64Cu-DOTATATE

Absorbed radiation doses of 177Lu-DOTATATE in organs using 64Cu-DOTATATE as an imagining surrogate will be summarized with descriptive statistics.

1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose

Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE

Absorbed doses to organs will be estimated using radiation dosimetry methods based on multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between 3D voxel-based and model-based dosimetry methods. Using 3D voxel-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare 3D voxel-based to model-based methods. Mean bias and 95% confidence intervals will be calculated.

Baseline and 120 hours post-dose