Peptide receptor radionuclide therapy with 177Lu-DOTATATE for patients with somatostatin receptor-expressing neuroendocrine tumors: the first US phase 2 experience.

Objective: Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs is a novel method of treatment in patients with metastatic neuroendocrine tumors (NETs). For the first time in the United States, we present preliminary results of the treatment with Lutetium (177)(Lu) DOTATATE in patients with progressive NETs.

Methods: Thirty-seven patients with grade 1 and grade 2 disseminated and progressive gastroenteropancreatic NET were enrolled in a nonrandomized, phase 2 clinical trial.

An extended phase II trial of iodine-125 methylene blue for sentinel lymph node identification in women with breast cancer.

Background: The aim of this study was to determine if an intraoperative injection of iodine-125-labeled methylene blue ((125)I-MB) is a sensitive and effective method for detecting SLNs in women with breast cancer.

Study Design: Sixty-two women were enrolled in an extended phase II trial using (125)I-MB to guide SLNB. All patients were anesthetized and then injected subcutaneously with 1 mCi (125)I-MB in the outer quadrant of the areola.

A phase I/II trial of 125I methylene blue for one-stage sentinel lymph node biopsy.

Background: Sentinel lymph node biopsy can be associated with delays in operating room schedule and with significant pain during the preoperative Tc colloid injection. To avoid these problems, we developed a novel radiolabeled blue dye that can be injected intraoperatively.

Methods: We performed a phase I/II trial (IND#70627) of sterile pyrogen-free I-methylene blue to identify sentinel nodes in patients with breast cancer.

Development of 125I-methylene blue for sentinel lymph node biopsy.

Background: Sentinel lymph node biopsy is an established alternative to complete lymph node dissection in some patients. We have developed a novel, radiolabeled methylene blue dye that may be a useful alternative to the traditional two-step procedure involving 99mTc-labeled colloid and unlabeled blue dye. We hypothesize that 125I-labeled methylene blue will be rapidly absorbed into the lymphatics and transported to the drainage basin containing the sentinel nodes.