Table 1 Overview of the research questions and setup of the subsequent studies
Research question (rat strain) | Study | Groups | Number | 177Lu-TATE (MBq) | RAD001 (dose, period) |
|---|---|---|---|---|---|
(A) Potential synergistic effect of RAD001 in combination with 177Lu-TATE (LEW/HanHsd) | 1 | Control | 7 | - | Placebo |
RAD only | 6 | - | 5.0Â mg/kg, 4.5 w | ||
177Lu-TATE low dose | 7 | 125 | Placebo | ||
177Lu-TATE high dose | 7 | 275 | Placebo | ||
RAD + 177Lu-TATE low dose | 7 | 125 | 5.0 mg/kg, 4.5 w | ||
RAD + 177Lu-TATE high dose | 7 | 275 | 5.0 mg/kg, 4.5 w | ||
(B) Prolonged follow-up of potential development of distant metastasis (LEW/HanHsd) | 2 | Control | 8 | - | Placebo |
Low-dose RAD | 8 | - | 2.5Â mg/kg, 4.5 w | ||
High-dose RAD | 8 | - | 5.0Â mg/kg, 4.5 w | ||
177Lu-TATE | 7 | 125 | Placebo | ||
177Lu-TATE + low-dose RAD | 8 | 125 | 2.5 mg/kg, 4.5 w | ||
177Lu-TATE + high-dose RAD | 7 | 125 | 5.0 mg/kg, 4.5 w | ||
(C) Influence of RAD001 on tumor uptake of 177Lu-DOTATATE (LEW/HanHsd) | 1 + 2 | 177Lu-TATE | 21 | 125 or 275 | Placebo |
RAD + 177Lu-TATE | 29 | 125 or 275 | 2.5 mg/kg or 5.0 mg/kg, 4.5 w | ||
(D) Effects of prolonged RAD001 treatment (LEW/SsNHsd) | 3 | Control | 8 | - | Placebo |
RAD | 8 | - | 5.0Â mg/kg, 4.5 w | ||
177Lu-TATE + RAD | 8 | 125 | 5.0 mg/kg, 4.5 w | ||
RAD prolonged treatment | 8 | - | 5.0Â mg/kg, 12 w | ||
177Lu-TATE + RAD prolonged treatment | 8 | 125 | 5.0 mg/kg, 12 w | ||
(E) Effects of PRRT on growth of metastases (LEW/SsNHsd) | 3 | High-dose 177Lu-TATE after diagnosis of metastases | 7 | 400 | - |