Drug updated on 11/5/2024
| Dosage Form | Injection (intravenous; 18.5 MBq/mL to 148 MBq/mL [0.5 mCi/mL to 4 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 five systematic review(s)/meta-analysis(es). [1-5]
- Neuroendocrine tumors (NETs) demonstrated higher true positivity rates with Fluorodopa F 18 PET (positron emission tomography), specifically (68)Ga-DOTA-TATE at 78.4% and (64)Cu-DOTATATE at 82.4%, compared to (111)In-DTPA-Octreotide at 63.7% and (99m)Tc-EDDA/HYNIC-TOC at 58.5%.
- Meningiomas showed effective detection and radiation therapy planning using (68)Ga-DOTA-SSTR PET, significantly influencing treatment decisions, with stable disease achieved in 66.6% of patients undergoing peptide receptor radionuclide therapy (PRRT).
- Pancreatic neuroendocrine tumors (pNETs) exhibited a pooled sensitivity of 79.6% (95% confidence interval: 71-87%) and specificity of 95% (95% confidence interval: 75-100%), indicating high accuracy for detection and staging of these tumors.
- For meningiomas, grade 1-2 hematological toxicity was the most common side effect observed in PRRT studies.
- In patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs), both (225)Ac-DOTATATE and (213)Bi-DOTATOC (177) demonstrated partial responses without significant hematological, renal, or hepatotoxicity, indicating a favorable safety profile.
- The studies encompassed various populations, including patients with NETs demonstrating higher true positivity rates with PET tracers; patients with meningiomas benefiting from (68)Ga-DOTA-SSTR PET for diagnosis and radiation therapy planning, achieving stable disease in a significant proportion; patients with GEP-NENs showing partial responses with targeted alpha-particle therapy without significant adverse effects; and patients with pNETs exhibiting high sensitivity (79.6%, 95% confidence interval: 71-87%) and specificity (95%, 95% confidence interval: 75-100%) for tumor detection.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ga 68 DOTATOC (gallium ga 68 edotreotide) Prescribing Information. | 2024 | UIHC PET Imaging Center, Iowa City, IA |
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 |
| Somatostatin Receptor Targeted PET-Imaging for Diagnosis, Radiotherapy Planning and Theranostics of Meningiomas: A Systematic Review of the Literature | 2022 | Diagnostics (Basel, Switzerland) |
| The Role of [(68)Ga]Ga-DOTA-SSTR PET Radiotracers in Brain Tumors: A Systematic Review of the Literature and Ongoing Clinical Trials | 2022 | Cancers |
| Targeted alpha-particle therapy in neuroendocrine neoplasms: A systematic review | 2021 | World Journal of Nuclear Medicine |
| Somatostatin Receptor PET/CT Imaging for the Detection and Staging of Pancreatic NET: A Systematic Review and Meta-Analysis | 2020 | Diagnostics (Basel, Switzerland) |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Gastroenteropancreatic neuroendocrine neoplasms: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. | 2020 | Annals of Oncology |