Clinical Trial:  177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry (LUMOD-ID)

Clinical Trial: 177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry (LUMOD-ID)

What is the LUMOD-ID trial? This is a randomized controlled clinical trial evaluating the impact of forward planning dosimetry for Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals), a radiopharmaceutical approved to treat neuroendocrine tumors by the U.S. FDA. The primary outcome measure is to determine objective response rate in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) treated with dosimetrically-determined LUTATHERA administration compared to active control.  This is done at 6 months after treatment completion along with a secondary outcome correlation of hematologic toxicities every 6 months for 5 years.  The remaining secondary outcome measures are after 5 years to…
Read More
Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors – PRRT vs Everolimus

Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors – PRRT vs Everolimus

US Trial I was delighted to see this clinical trial which looks at the efficacy of PRRT (Lu177 dotatate) vs the efficacy of Everolimus (Afinitor).  The latter is approved for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease (US FDA wording, Europe is similar). What is this trial? This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in…
Read More