Article Figures & Data
Figures
- FIGURE 1.
(A) Whole-body clearance curve for all cohorts. (B) Whole-body clearance curves by cohort. (C) Blood clearance curve of 124I-omburtamab displayed in aggregate decay-corrected mean values for all patients. (D) Blood clearance curves for patients by cohort. %ID/L = percentage injected dose per liter.
- FIGURE 2.
124I-omburtamab lesion and whole-body distribution in 8-y-old female patient. Baseline MRI showing 1.3 × 1.2 cm eccentric mass centered within left lateral pons extending to left cerebral peduncle. 124I-omburtamab infusion activity was 25.9 MBq. Imaging was performed on day of infusion (D0) and on days 2 (D2), 3 (D3), 6 (D6), and 8 (D8) with whole-body (A) and head imaging (B). High activity is noted at tumor site until last imaging time point (D8). Low activity systemic distribution is noted on D2 as excreted activity in kidneys and bladder, thyroid and stomach, and liver that decreased from D3 to D8.
- FIGURE 3.
(A) Lesion uptake and radiation-absorbed dose of 124I-omburtamab show high concentration within tumor. (B) Radiation-absorbed dose in lesion increases with increased activity over cohorts. (C) Lesion–to–whole-body ratio of radiation-absorbed dose is high, highlighting safe margin and high therapeutic index with local administration.
- FIGURE 4.
Distribution volume of administered activity. Linear regression between Vd (in mL) and administered activity (in MBq) of 124I-omburtamab, with slope of 0.046 mL/MBq, ordinate intercept of 3.8 mL, and correlation coefficient of 0.83. Regression is highly statistically significant (P < 0.0005), as determined by ANOVA using F statistic.
- FIGURE 5.
Example of imaging in 8-y-old patient. Baseline MRI showing 3.5 × 2.8 cm mass centered in pons extending to right cerebral peduncle and brachium pontis. 124I-omburtamab infusion activity was 148 MBq. Imaging was performed on day of infusion (D0), day 4 (D4), and day 6 (D6), with whole-body and head imaging. High activity is noted at site of tumor until last imaging time point (D6). Infusion time was 10 h. First imaging time point was 16 h after initiation. D1 scan shows activity in spinal canal and systemic activity in liver, stomach, and bladder. Further systemic distribution is noted on D2 as excreted activity in kidneys and bladder, thyroid and stomach, and liver that decreased from D4 to D6.
Tables
Cohort Administered activity level (MBq)* Number of patients Age range (y) Administered activity range (MBq)* Maximum lesion size (cm) Volume infused (mL) 1 9.25 (0.25) 3 3–8 8.88–9.99 (0.24–0.27) 3.1–3.3 0.24–0.27 2 18.5 (0.5) 3 5–6; 17 15.9–20.0 (0.43–0.54) 3.1–5.5 0.47–0.63 3 27.75 (0.75) 3 3–7 25.9–27.0 (0.70–0.73) 1.3–4.2 0.69–0.77 4 37 (1.0) 4 3–7; 16, 17 34.8–38.9 (0.94–1.05) 2.3–3.2 0.99–1.05 5 92.5 (2.5) 3 5–6; 17 96.9–98.4 (2.62–2.66) 4.1–4.2 2.56–2.61 6 120.25 (3.25) 3 4–7 117.7–122.1 (3.18–3.3) 3.0–4.1 3.42–3.57 7 148 (4.0) 14 3–11 142.5–158.4 (3.85–4.28) 2.1–5.0 3.84–4.54 8 222 (6) 6 3–8; 12, 16 217.9–243.46 (5.87–6.58) 2.1–4.6 4.18–8.56 9 296 (8) 3 3, 11, 18 281.2–288.6 (7.6–7.8) 2.2–3.6 6.17–8.11 10 370 (10) 2 5, 10 362.6–370.7 (9.83–10.02) 3.6,3.9 9.71–11.95 ↵* Activity in mCi given in parentheses.
Organ or tissue Absorbed dose (mGy/MBq) Mean SD Minimum Maximum Adrenal glands 0.38 0.22 0.06 0.98 Brain 4.11 2.09 1.04 9.38 Breasts 0.25 0.14 0.03 0.66 Gallbladder wall 0.43 0.25 0.07 1.01 Lower large intestine wall 0.37 0.23 0.03 0.97 Small intestine 0.38 0.23 0.04 0.97 Stomach wall 1.14 0.93 0.08 3.72 Upper large intestine wall 0.38 0.23 0.04 0.96 Heart wall 0.45 0.24 0.10 1.02 Kidneys 0.37 0.22 0.06 1.11 Liver 0.92 0.77 0.09 3.17 Lungs 0.28 0.14 0.10 0.76 Muscle 0.34 0.18 0.06 0.84 Ovaries 0.39 0.24 0.03 0.98 Pancreas 0.45 0.25 0.06 1.09 Red marrow 0.39 0.17 0.11 0.90 Osteogenic cells 0.60 0.26 0.19 1.36 Skin 0.29 0.14 0.07 0.71 Spleen 0.37 0.24 0.04 1.28 Testes 0.32 0.20 0.02 0.89 Thymus 0.33 0.18 0.06 0.85 Thyroid 1.15 1.12 0.13 7.14 Urinary bladder wall 2.01 2.42 0.08 12.10 Uterus 0.47 0.30 0.04 1.49 Total body 0.58 0.25 0.20 1.22 Effective dose (mSv/MBq) 0.69 0.28 0.26 1.59
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