Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Gallium Ga 68 dotatate (Netspot, 68Ga-DOTATATE): what the evidence says
At a glance
What it is: dotatate (DOTA-Tyr3-octreotate) is an 8-amino-acid cyclic peptide, a relative of octreotide, attached to a chelator that holds radioactive gallium-68. It binds somatostatin receptors, so tumors carrying them light up on a PET scan. Approved as the Netspot kit (Jun 2016) for locating these tumors in adults and children. It is used only for imaging, not treatment. R1, R2
What the evidence says: Human a meta-analysis estimated about 91% sensitivity and 91% specificity for neuroendocrine tumors, and a prospective study of 131 patients found it detected far more lesions than older octreotide scans or CT/MRI. R3, R4
Biggest risks: low radiation dose adds to lifetime exposure; allergic reactions (mostly rash and itching) are reported, and uptake in other tissues can be misread as tumor. R2, R3
Rating
| Human Human evidence | Strong: meta-analysis plus prospective diagnostic study R3, R4 |
| Animal Animal / lab evidence | Not reviewed |
| Regulatory | FDA-approved R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R5, R6, R7 · not named by WADA R8 |
| Established human dose | Yes, label dose (see Study details) |
Evidence verdict: Finding somatostatin-receptor-positive neuroendocrine tumors on PET: Strong (diagnostic-accuracy meta-analysis and prospective study) · Treatment: not a treatment
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: diagnostic-accuracy studies, not outcome RCTs; most are single-center.
What is it?
Related pages: lutetium-lu-177-dotatate, octreotide, lanreotide.
Does it work?
- Human Meta-analysis (42 studies): sensitivity 90.9%, specificity 90.6%; harms rare (6 of 974). R3
- Human Prospective study (131 patients): detected 95.1% of lesions vs 45.3% for CT/MRI and 30.9% for indium-111 octreotide imaging. R4
Is it safe?
- Warnings: radiation risk, hypersensitivity reactions, risk of image misinterpretation. R2
- Nausea, vomiting and injection-site pain reported after approval. R2
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: FDA-approved, prescription diagnostic (Netspot kit), prepared and given only in nuclear medicine settings. R1, R2
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R5, R6, R7
- Sport: not named on WADA's 2026 Prohibited List. R8
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Deppen 2016 meta-analysis | 42 studies, NET patients | IV, PET imaging | Per study | Single scan | Sensitivity 90.9%, specificity 90.6% | PMID 26769864 |
| Sadowski 2016 | 131 patients with GEP-NETs | IV, PET imaging | Per study | Single scan | 95.1% of lesions detected | PMID 26712231 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)
- R1 Drugs@FDA, Netspot (kit for gallium Ga 68 dotatate), application NDA208547 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA208547
- R2 Netspot prescribing information, label published Jul 7, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b2b3be70-17d8-4093-896c-f1c54a2cf242
- R3 Deppen SA, et al. J Nucl Med. 2016. PMID 26769864
- R4 Sadowski SM, et al. J Clin Oncol. 2016. PMID 26712231
- R5 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R6 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R7 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R8 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Gallium Ga 68 dotatate (Netspot, 68Ga-DOTATATE). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).