Drug updated on 4/26/2024
| Dosage Form | Injection (intravenous; up to 218 MBq/mL [5.89 mCi/mL]) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Summary
- Gallium Ga 68 dotatate (NETSPOT) is indicated for use with positron emission tomography (PET) imaging to localize somatostatin receptor-positive neuroendocrine tumors in both adult and pediatric patients, enhancing the precision of tumor localization which is critical for diagnosis, staging, and treatment planning.
- The information was derived from a study that falls under the category of Systematic Reviews / Meta-Analyses.
- NETSPOT's effectiveness was compared to other radiolabeled peptides used for imaging neuroendocrine tumors through PET and single photon computed emission tomography (SPECT). It showed higher true positivity rates than In-DTPA-Octreotide and Tc-EDDA/HYNIC-TOC but slightly lower than Cu-DOTATATE.
- In terms of safety and effectiveness comparison between PET tracers like gallium Ga 68 dotatate (NETSPOT), they have shown superior diagnostic capability due to their higher true positive rates when compared to SPECT agents. This suggests that NETSPOT offers better diagnostic performance in locating neuroendocrine tumors accurately.
- The study does not specify distinct population types or subgroups; however, it indicates broad applicability as NETSPOT can be used by both adult and pediatric patients without any specific subgroup restrictions mentioned.
- Safety information about gallium Ga 68 dotatate (NETSPOT) wasn't directly provided within this study; however, its high true positivity rate indirectly suggests potential benefits such as achieving accurate diagnoses with fewer false negatives which are crucial for effective management and treatment of Neuroendocrine Tumors.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| NETSPOT (gallium Ga 68 dotatate) Prescribing Information. | 2023 | Advanced Accelerator Applications USA, Inc., Millburn, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Head-to-head comparison between peptide-based radiopharmaceutical for PET and SPECT in the evaluation of neuroendocrine tumors: A systematic review. | 2022 | Current Issues in Molecular Biology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| SNMMI procedure standard/EANM practice guideline for SSTR PET: Imaging neuroendocrine tumors. | 2023 | Journal of Nuclear Medicine |