No subgroup analyses were done because of limited data for sex, race or age of the trial participants. Were there any differences in how well the drug worked in clinical trials among sex, race and age groups? In 29 out of 34 patients where there was no tumor recurrence, Ga 68 dotatate PET also showed no tumor recurrence. In 23 out of 29 patients with tumor recurrence, gallium Ga 68 dotatate PET correctly located the tumor. In Trial C (published study), 63 patients with known neuroendocrine tumors were evaluated for tumor recurrence by combined CT and/or MRI and SPECT and compared to scans obtained from gallium Ga 68 dotatate PET. In 7 out of 68 patients it was falsely positive. In 61 out of 68 patients, where CT and/or MRI and SPECT did not identify a NET, gallium Ga 68 dotatate also did not identify a NET. It was falsely negative in 7 out of 36 of these patients. In 29 out of 36 of these patients, gallium Ga 68 dotatate PET correctly identified the NET site. In Trial B (published study), 36 out of 104 patients with suspected neuroendocrine tumors were found by CT and/or MRI and SPECT to have pathology confirmed NET. gallium Ga 68 dotatate was negative in 26 out of 28 patients in whom CT and/or MR imaging was negative. Out of 50 patients with NETs localized by CT and/or MR imaging, gallium Ga 68 dotatate was positive in 48 patients including 13 patients in whom In 111 pentetreotide was negative. Among 78 patients in whom CT and/or MR images and In 111 pentetreotide images were available, gallium Ga 68 dotatate PET was in agreement with the CT and/or MR images in 74 patients. The reads were compared to CT and/or MR images and to indium In 111 pentetreotide images obtained with Single Photon Emission Computed Tomography (SPECT) within previous 3 years. The images were read by two independent readers blinded to clinical information. ![]() In Trial A, 97 adult patients with known or suspected neuroendocrine tumors (NETs) were evaluated with gallium Ga 68 dotatate. The efficacy of NETSPOT was established in three open-label, single center trials (Study A-C). What are the benefits of this drug (results of trials used to assess efficacy)? NETSPOT shows the sites of neuro-endocrine tumors. NETSPOT is injected into a vein (intravenous) in preparation for an imaging test (called positron emission tomography scan or PET scan) to help detect the tumor. NETs are rare tumors that develop in certain hormone-producing cells of the body’s neuro-endocrine system. NETSPOT is a drug for detection of a specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs). NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection)ĭRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? Refer to the NETSPOT (kit for the preparation of gallium Ga 68 dotatate injection) Prescribing Information for complete information. Always speak to your health provider about the risks and benefits of a drug. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.ĭo not rely on Snapshots to make decisions regarding medical care. The “MORE INFO” bar shows more detailed, technical content for each section. 1974 15(6):466–467.The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. Radionuclidic contamination of eluates from fission product molybdenum-technetium generators. Rapid determination of Mo-99 in separated Tc-99m. Vienna, Austria: International Atomic Energy Agency 1971:71–82. In: Radiopharmaceuticals from Generator-Produced Radionuclides. Some chemical and analytical problems connected with technetium-99m generators. Food and Drug Administration February 8, 2018. FDA and NRC pave way for the first domestic supply of the most commonly used medical isotope in diagnostic imaging. Preliminary Observations on the Use of Six-hour Tc-99m as a Tracer in Biology and Medicine. London, United Kingdom: Pergamon Press 1958:50–70. Paper presented at: Proceedings of the First UNESCO Conference. Development of methods for the production of certain short-lived radioisotopes. Stang LG Jr, Tucker WD, Doering RF, et al. Radionuclide Generators for Biomedical Applications. Organization for Economic Co-operation and Development. 2017 Medical Isotope Supply Review: 99Mo/ 99mTc Market Demand and Production Capacity Projection 2017–2022.
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