Drug updated on 12/11/2024
| 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
- Indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Imaging Uptake and Tumor-to-Background Ratios: In patients with neuroendocrine tumors (NETs), the uptake of Gallium-68-labeled DOTATATE showed no significant change at primary and metastatic sites following somatostatin analog (SSA) therapy, though the tumor-to-liver/background ratio increased post-treatment.
- True Positivity Rates: Radiolabeled peptides varied in true positivity rates, with (111)In-DTPA-Octreotide at 63.7%, (99m)Tc-EDDA/HYNIC-TOC at 58.5%, (68)Ga-DOTATATE/TOC at 78.4%, and (64)Cu-DOTATATE at 82.4%; PET tracers (68)Ga-DOTATATE/TOC and (64)Cu-DOTATATE demonstrated higher rates than single photon computed emission tomography (SPECT) agents.
- Diagnostic Performance for Pancreatic NETs: The sensitivity and specificity of (68)Ga-DOTATATE in SSR-PET/CT imaging for primary pancreatic NETs (pNETs) were 79.6% and 95%, respectively, with pooled detection rates of 81% for patient-based and 92% for lesion-based analysis.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| NETSPOT (gallium Ga 68 dotatate) Prescribing Information. | 2023 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Effects of somatostatin analogs on uptake of radiolabeled somatostatin analogs on imaging: a systematic review and meta-analysis | 2023 | Quantitative Imaging in Medicine and Surgery |
| 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 |
| Somatostatin Receptor PET/CT Imaging for the Detection and Staging of Pancreatic NET: A Systematic Review and Meta-Analysis | 2020 | Diagnostics |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| SNMMI procedure standard/EANM practice guideline for SSTR PET: Imaging neuroendocrine tumors. | 2023 | Journal of Nuclear Medicine |
| Consensus on molecular imaging and theranostics in neuroendocrine neoplasms | 2021 | European Journal of Cancer |