Gallium Ga-68 dotatate (NETSPOT)

Also known as: 68Ga-DOTATATE · 68Ga-DOTA-TATE · gallium Ga 68 dotatate

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 1 application

Randomized controlled trials 2 of 760 publications on PubMed

Registered clinical trials 118 44 active

Adverse event reports 202 26 classified as serious

Gallium Ga-68 dotatate (NETSPOT) is an FDA-approved drug, marketed as Netspot (first approval: June 1, 2016).
PubMed lists 760 publications mentioning it, including 2 randomized controlled trials and 1 animal-only study.
ClinicalTrials.gov lists 118 registered studies testing it (44 active).
FDA's adverse event system (FAERS) holds 202 reports mentioning it; 26 classified as serious. Reports do not prove causation.

Research topics

Positron Emission Tomography Computed Tomography 74
Organometallic Compounds 73
Neuroendocrine Tumors 36
Radiopharmaceuticals 29
Positron-Emission Tomography 28
Gallium Radioisotopes 20
Fluorodeoxyglucose F18 17
Receptors, Somatostatin 16
Magnetic Resonance Imaging 15
Paraganglioma 14

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application	Product	Status	First approval	Sponsor
NDA208547	NETSPOT	Approved, marketed	June 1, 2016	NOVARTIS

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

All publications 760
Human (MeSH) 519
Animal only 1
Clinical trials 19
Randomized controlled trials 2
Systematic reviews & meta-analyses 6
Case reports 317
Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Characterizing bone metastases and skeletal-related events in patients with well-differentiated neuroendocrine neoplasms utilizing 68Gallium-DOTATATE positron emission tomography. Human study 2026 Journal of neuroendocrinology
A Tale of 3 Tracers: Contrasting Uptake Patterns of 18F-FDG, 68Ga-DOTATATE, and 18F-MFBG in a Pediatric Neuroblastoma Patient. Unclassified 2026 Clinical nuclear medicine
A Consistently Elevated Pineal Gland Uptake of 18F-MFBG as a Physiological Normal Variant. Unclassified 2026 Clinical nuclear medicine
68Ga-DOTATATE PET/CT Detection of Hypertrophic Osteoarthropathy in a Pediatric Patient With Neuroblastoma Following Anti-GD2 Immunotherapy. Case report 2026 Clinical nuclear medicine
Marked Hypokalemia at Presentation in an Adolescent with Ectopic Adrenocorticotropic Hormone Syndrome Secondary to a Bronchial Carcinoid Tumor: A Case Report. Case report 2026 Hormone research in paediatrics
Composite pheochromocytoma-ganglioneuroma secreting vasoactive intestinal peptide. Unclassified 2026 Endocrinology, diabetes & metabolism case reports
Potential bone marrow-driven reduction of circulating inflammatory monocytes by semaglutide in Type 2 diabetes. Unclassified 2026 European heart journal
Pulmonary Metastasis of Grade 1 Meningioma Mimicking a Carcinoid Tumor: A Case Report with FDG PET/CT, Ga-68 DOTATATE PET/CT, and Pathological Confirmation. Case report 2026 World journal of nuclear medicine
One Tracer, Whole Syndrome: CAIX-Targeted PET Unmasks the Multisystem Tumor Landscape of Von Hippel-Lindau Disease. Case report 2026 Clinical nuclear medicine
Predicting Response to Somatostatin Analog Therapy in GEP-NET Liver Metastases: A Machine Learning Approach with ⁶⁸Ga-DOTATATE and ¹⁸F-FDG PET/CT. Unclassified 2026 Academic radiology

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered: 118
Active: 44
With posted results: 17

Conditions studied

Neuroendocrine Tumors 32
Neuroblastoma 12
Paraganglioma 7
Meningioma 7
Medulloblastoma 6
Pheochromocytoma 5
Neuroendocrine Tumor 5
Carcinoid Tumors 5
Neuroendocrine Carcinoma 4
Medullary Thyroid Carcinoma 3
Neuroendocrine Neoplasms 3
Recurrent Meningioma 3

Study	Status	Phase	Start
A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies NCT07621146 British Columbia Cancer Agency	Not yet recruiting	—	November 30, 2026
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer NCT06991738 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Not yet recruiting	Phase 1, Phase 2	November 4, 2026
68Ga-NYM215 in NENs NCT07835906 Peking Union Medical College Hospital	Not yet recruiting	Phase 1, Phase 2	September 10, 2026
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer NCT04529044 OHSU Knight Cancer Institute	Recruiting	Phase 2	June 30, 2026
Ultralow Dose PET Imaging of SSTR2 Radiotracer Uptake NCT07284589 Akiva Mintz	Recruiting	Phase 2	December 11, 2025
Comparative Evaluation of 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MRI in Thyroid Eye Disease NCT07835607 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Recruiting	—	November 14, 2025
RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma NCT07150806 Joshua Palmer	Recruiting	Phase 1, Phase 2	November 12, 2025
Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors. NCT07150546 Emory University	Recruiting	Phase 1	October 14, 2025
[212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers NCT06479811 National Cancer Institute (NCI)	Recruiting	Phase 1	August 19, 2025
Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging NCT07472049 University of Edinburgh	Recruiting	—	July 31, 2025

Show 40 more studies

Study	Status	Phase	Start
Research on the Application of 68Ga-DOTA-CCK-FS PET/CT in MTC NCT07138716 Luo Yaping	Recruiting	N/A	May 10, 2025
Graft Failure and Consequences of Coronary Artery Bypass Graft Surgery NCT06800430 University of Edinburgh	Recruiting	—	March 28, 2025
Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy NCT06427798 National Cancer Institute (NCI)	Recruiting	Phase 1, Phase 2	February 7, 2025
61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET) NCT06455358 University Hospital, Basel, Switzerland	Recruiting	Phase 1, Phase 2	February 5, 2025
Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer NCT06611891 University Hospital, Grenoble	Recruiting	Phase 3	January 6, 2025
Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma NCT07195500 Nanjing First Hospital, Nanjing Medical University	Recruiting	—	December 25, 2024
68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue Sarcomas NCT06500065 Ohio State University Comprehensive Cancer Center	Recruiting	N/A	September 30, 2024
Al18F-NOTA-LM3 PET/CT in Patients With Pheochromocytoma and Paraganglioma NCT07288931 Peking Union Medical College Hospital	Recruiting	N/A	August 6, 2024
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. NCT06379217 Novartis Pharmaceuticals	Active, not recruiting	Phase 1	July 29, 2024
Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort NCT06256705 Assistance Publique - Hôpitaux de Paris	Recruiting	N/A	March 25, 2024
Evaluate the Diagnostic Efficacy, Pharmacokinetics and Safety of 68Ga-DOTATATE Injection PET/CT in NETs NCT07119242 HTA Co., Ltd.	Active, not recruiting	Phase 3	January 8, 2024
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells NCT05691465 National Cancer Institute (NCI)	Recruiting	Phase 2	December 27, 2023
Incremental Value of Delayed 68Ga-DOTATATE PET/MR in the Detection of Liver Metastases NCT07898904 First Affiliated Hospital of Fujian Medical University	Recruiting	—	December 1, 2023
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome NCT07350707 Peking Union Medical College Hospital	Recruiting	Phase 1, Phase 2	June 12, 2023
Al18F-NOTA-LM3 PET/CT in Patients With TIO NCT07366099 Peking Union Medical College Hospital	Recruiting	N/A	March 30, 2023
Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication NCT06467968 Central Hospital, Nancy, France	Recruiting	N/A	February 2, 2023
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET) NCT04086485 National Cancer Institute (NCI)	Recruiting	Phase 1, Phase 2	October 3, 2022
Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma NCT07064746 Nanjing First Hospital, Nanjing Medical University	Recruiting	—	July 10, 2022
68Ga-DOTATATE Neuroblastoma Imaging Pilot NCT04559217 Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Recruiting	Phase 2	December 6, 2021
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer NCT04927416 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Recruiting	Phase 2	October 25, 2021
18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor NCT05069220 Peking Union Medical College Hospital	Recruiting	Early phase 1	September 1, 2021
Use of 68Ga-DOTATOC PET/CT-enterography for Detection of the Primary Lesion in Neuroendocrine Tumors of the Small Bowel NCT06773624 European Institute of Oncology	Recruiting	N/A	April 23, 2021
Study of PRRT in Metastatic, WHO Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery NCT04609592 Stanford University	Active, not recruiting	Phase 1	March 17, 2021
Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumors NCT04804371 University Health Network, Toronto	Active, not recruiting	N/A	March 4, 2021
Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver NCT04544098 Memorial Sloan Kettering Cancer Center	Active, not recruiting	Early phase 1	September 2, 2020
Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors NCT04074135 National Cancer Institute (NCI)	Recruiting	Phase 2	June 2, 2020
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy NCT04082520 Mayo Clinic	Recruiting	Phase 2	April 14, 2020
An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors NCT04040088 Mayo Clinic	Active, not recruiting	Early phase 1	September 23, 2019
68Ga-DOTATOC PET for the Evaluation of Gastroenteropancreatic Neuroendocrine Tumours NCT06155318 IRCCS San Raffaele	Recruiting	—	September 5, 2019
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors. NCT04081701 Weill Medical College of Cornell University	Recruiting	Phase 4	September 4, 2019
DOTATOC PET/CT for Imaging NET Patients NCT03583528 British Columbia Cancer Agency	Active, not recruiting	—	July 11, 2018
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma NCT03206060 National Cancer Institute (NCI)	Recruiting	Phase 2	October 10, 2017
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome NCT02019706 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Recruiting	Phase 2	February 12, 2014
Studies on Tumors of the Thyroid NCT00001160 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Recruiting	—	June 1, 1977
Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC NCT04298541 Weill Medical College of Cornell University	Withdrawn	Phase 2	Aug 2026
68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High Risk Meningioma NCT07353229 Thomas Jefferson University	Suspended	Phase 1	September 5, 2025
Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors NCT06091748 Jiangsu HengRui Medicine Co., Ltd.	Completed	Phase 3	February 22, 2024
Molecular Imaging in Fabry Disease of the Heart NCT06226987 University of Cambridge	Unknown status	—	January 2, 2024
ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors NCT06188468 The First Affiliated Hospital of Xiamen University	Completed	N/A	October 1, 2023
Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma NCT06520319 First Affiliated Hospital of Fujian Medical University	Unknown status	Phase 1	June 21, 2023

All 118 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports: 202
Serious: 26
With death outcome: 3

Most reported reactions

Nausea 81
Scan gallium abnormal 29
Vomiting 28
Abdominal pain 22
Injection site pain 20
Flushing 19
Chest pain 12
Dizziness 9
Burning sensation 8
Urticaria 8
Erythema 7
Hyperhidrosis 7

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

NETSPOT HUMAN PRESCRIPTION DRUG Advanced Accelerator Applications USA, Inc July 6, 2026

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.