Table 1.
Subject Information.
Figure 1.
Consort diagram and clinical outcome of enrolled patients.
Patients were taken off of conventional therapies from two weeks prior to and 30 days after treatment with 131I-CLR1404. After treatment with 131I-CLR1404, patients underwent nuclear medicine procedures for 14 days and were followed for safety for 42 days.
Figure 2.
Renal clearance of 131I-CLR1404.
The cumulative fraction of 131I-CLR1404 within the urine is shown following a single dose injection of 370 MBq of 131I-CLR1404. The top graph shows each subject individually while the bottom graph shows the average of the group with the standard deviation represented with error bars. These data are used as input into OLINDA/EXM for dosimetry calculations.
Figure 3.
Whole body conjugate-view planar images for subject 301.
Images are shown for 15–30 minutes, 4, 24, 48, 72 hours, 6 and 14 days post injection, respectively. Because the agent is metabolized in the hepatobiliary system, there is evidence of 131I-CLR1404 within the liver and intestines at relatively late time points.
Table 2.
Dosimetry Results Calculated by OLINDA/EXM.
Figure 4.
Imaging data from the optional SPECT/CT scans.
Top: Day 6 SPECT/CT Images for a subject with colorectal cancer that metastasized to the lung (301). The three columns represent an axial, coronal, and sagittal slice, respectively. The top row shows the diagnostic quality CT alone while the bottom row shows the SPECT data overlayed onto the diagnostic CT. Bottom: Day 6 SPECT/CT Images for a subject with metastatic prostate cancer (402). The top row shows the low dose CT data alone while the bottom row shows the SPECT data overlayed onto the CT data. Note the increased uptake in the osteolytic lesion. The sagittal and coronal slices are of lower resolution compared to the axial plan because the CT was not of diagnostic quality; it was only used for attenuation correction of the SPECT data. A diagnostic quality CT of this subject was unavailable.
Table 3.
Individual and Mean Pharmacokinetic Parameters following a Single Dose Infusion of 10 mCi of 131I-CLR1404.
Figure 5.
Plasma pharmacokinetics of 127I-CLR1404.
The remaining fraction of 127I-CLR1404 within the plasma is plotted over time. The top graph shows each individual subject while the bottom graph shows the average of the group with the standard deviation represented with error bars.
Table 4.
Adverse Events (AE).