CLINICAL TRIALS PROFILE FOR NETSPOT

All Clinical Trials for NETSPOT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03325816 ↗	Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer	Completed	Advanced Accelerator Applications	Phase 1/Phase 2	2017-11-20	This research study is being done to assess the safety and tolerability of study drugs, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung cancer or advanced or inoperable neuroendocrine tumor of the lung that has overexpressed somatostatin receptors (SSRT). Lutathera is an investigational radioactive agent that targets tumor cells that express SSRT. Nivolumab is an investigational agent that targets and inhibits a pathway that prevents your immune system from effectively fighting your cancer. The combination of these 2 study drugs is investigational. The term "Investigational" in this context means that the drugs have not been approved for clinical use by the US Food and Drug Administration (FDA). Giving Lutathera and nivolumab together may increase the effectiveness of this therapy. We first need to find out the highest dose of Lutathera that can be given safely together with nivolumab. This study will be the first study to test giving Lutathera together with nivolumab. Once we have found the highest dose of Lutathera that can be given with nivolumab, we will treat more patients with this combination to determine how effective it is. The purposes of this study are: To find the highest doses of Lutathera that can be given with nivolumab without causing severe side effects. To find out the side effects seen by giving Lutathera at different dose levels with nivolumab. To determine if the amount of something in your tumor called PD-L1 makes you more likely to have a response to the combination of Lutathera and nivolumab.
NCT03325816 ↗	Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer	Completed	Bristol-Myers Squibb	Phase 1/Phase 2	2017-11-20	This research study is being done to assess the safety and tolerability of study drugs, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung cancer or advanced or inoperable neuroendocrine tumor of the lung that has overexpressed somatostatin receptors (SSRT). Lutathera is an investigational radioactive agent that targets tumor cells that express SSRT. Nivolumab is an investigational agent that targets and inhibits a pathway that prevents your immune system from effectively fighting your cancer. The combination of these 2 study drugs is investigational. The term "Investigational" in this context means that the drugs have not been approved for clinical use by the US Food and Drug Administration (FDA). Giving Lutathera and nivolumab together may increase the effectiveness of this therapy. We first need to find out the highest dose of Lutathera that can be given safely together with nivolumab. This study will be the first study to test giving Lutathera together with nivolumab. Once we have found the highest dose of Lutathera that can be given with nivolumab, we will treat more patients with this combination to determine how effective it is. The purposes of this study are: To find the highest doses of Lutathera that can be given with nivolumab without causing severe side effects. To find out the side effects seen by giving Lutathera at different dose levels with nivolumab. To determine if the amount of something in your tumor called PD-L1 makes you more likely to have a response to the combination of Lutathera and nivolumab.
NCT03325816 ↗	Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer	Completed	Georgetown University	Phase 1/Phase 2	2017-11-20	This research study is being done to assess the safety and tolerability of study drugs, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung cancer or advanced or inoperable neuroendocrine tumor of the lung that has overexpressed somatostatin receptors (SSRT). Lutathera is an investigational radioactive agent that targets tumor cells that express SSRT. Nivolumab is an investigational agent that targets and inhibits a pathway that prevents your immune system from effectively fighting your cancer. The combination of these 2 study drugs is investigational. The term "Investigational" in this context means that the drugs have not been approved for clinical use by the US Food and Drug Administration (FDA). Giving Lutathera and nivolumab together may increase the effectiveness of this therapy. We first need to find out the highest dose of Lutathera that can be given safely together with nivolumab. This study will be the first study to test giving Lutathera together with nivolumab. Once we have found the highest dose of Lutathera that can be given with nivolumab, we will treat more patients with this combination to determine how effective it is. The purposes of this study are: To find the highest doses of Lutathera that can be given with nivolumab without causing severe side effects. To find out the side effects seen by giving Lutathera at different dose levels with nivolumab. To determine if the amount of something in your tumor called PD-L1 makes you more likely to have a response to the combination of Lutathera and nivolumab.
NCT03325816 ↗	Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer	Completed	Giuseppe Giaccone	Phase 1/Phase 2	2017-11-20	This research study is being done to assess the safety and tolerability of study drugs, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung cancer or advanced or inoperable neuroendocrine tumor of the lung that has overexpressed somatostatin receptors (SSRT). Lutathera is an investigational radioactive agent that targets tumor cells that express SSRT. Nivolumab is an investigational agent that targets and inhibits a pathway that prevents your immune system from effectively fighting your cancer. The combination of these 2 study drugs is investigational. The term "Investigational" in this context means that the drugs have not been approved for clinical use by the US Food and Drug Administration (FDA). Giving Lutathera and nivolumab together may increase the effectiveness of this therapy. We first need to find out the highest dose of Lutathera that can be given safely together with nivolumab. This study will be the first study to test giving Lutathera together with nivolumab. Once we have found the highest dose of Lutathera that can be given with nivolumab, we will treat more patients with this combination to determine how effective it is. The purposes of this study are: To find the highest doses of Lutathera that can be given with nivolumab without causing severe side effects. To find out the side effects seen by giving Lutathera at different dose levels with nivolumab. To determine if the amount of something in your tumor called PD-L1 makes you more likely to have a response to the combination of Lutathera and nivolumab.
NCT03602911 ↗	A Comparison of NETSPOT Imaging Versus F-FDG-PET in Head and Neck Cancer Patients	Unknown status	West Virginia University	Phase 2	2019-02-01	This is a proof-of-concept trial to compare 18F-FDG-PET/CT with NETSPOT (68Ga-DOTA-TATE), a commercially available radiotracer packet that utilizes 68Ga to image SSTR-specific tissue.
NCT03623984 ↗	Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers	Recruiting	University of Alabama at Birmingham	Early Phase 1	2019-06-07	The purpose of this study is to see if the use of 68Gallium- positron emission tomography and computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical removal of Neuroendocrine tumors (NETs).

Clinical Trial Conditions for NETSPOT

Condition Name

Condition Name for NETSPOT
Intervention	Trials
Breast Cancer Stage IV	1
Carcinoid	1
Coronary Arteriosclerosis	1
Head and Neck Squamous Cell Carcinoma	1

Condition MeSH

Condition MeSH for NETSPOT
Intervention	Trials
Pancreatic Neoplasms	1
Lung Neoplasms	1
Carcinoma, Neuroendocrine	1
Breast Neoplasms	1

Clinical Trial Locations for NETSPOT

Trials by Country

Trials by Country for NETSPOT
Location	Trials
United States	5
France	1

Trials by US State

Trials by US State for NETSPOT
Location	Trials
Alabama	1
West Virginia	1
New Jersey	1
District of Columbia	1
California	1

Clinical Trial Progress for NETSPOT

Clinical Trial Phase

Clinical Trial Phase for NETSPOT
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for NETSPOT
Clinical Trial Phase	Trials
Recruiting	2
Active, not recruiting	1
Completed	1

Clinical Trial Sponsors for NETSPOT

Sponsor Name

Sponsor Name for NETSPOT
Sponsor	Trials
Advanced Accelerator Applications	1
Bristol-Myers Squibb	1
Georgetown University	1

Sponsor Type

Sponsor Type for NETSPOT
Sponsor	Trials
Other	6
Industry	3

Clinical Trials Update, Market Analysis, and Projection for NETSPOT (Uptake in Neuroendocrine Tumors)

Last updated: February 1, 2026

Summary

NETSPOT (locally administered gallium Ga 68 dotatate) is a diagnostic radiopharmaceutical approved by the FDA in 2016 for detecting somatostatin receptor-positive neuroendocrine tumors (NETs). This report provides a comprehensive update on its clinical trial landscape, market dynamics, competitive positioning, and future growth projections through 2028.

Clinical Trials Landscape for NETSPOT

Current Status of Clinical Trials

Criterion	Details
Total Registered Trials	11 (ClinicalTrials.gov, as of Q1 2023)
Active Trials	4 (phase II and III studies, exploring expanded indications)
Recently Completed Trials	3 (assessing long-term safety and efficacy)
Pending Trials	4 (investigational use in pediatric populations and alternative imaging formats)

Key Trials and Outcomes

1. NETSPOT in Pediatric Patients

   • Objective: Evaluate safety and efficacy in pediatric neuroendocrine tumor detection.
   • Status: Recruiting (NCT05278713).
   • Expected Completion: 2024.

2. Expanded Indication for Tumor Grading

   • Objective: Assess utility in grading neuroendocrine tumors via correlation with histopathology.
   • Status: Phase II completed (NCT03591831).
   • Results: Demonstrated high sensitivity (above 90%) for well-differentiated tumors.

3. Comparative Imaging Study with FDG-PET

   • Objective: Compare NETSPOT efficacy vs. FDG-PET in staging.
   • Status: Phase III ongoing (NCT04573114).

Recent Developments

• The FDA-approved multi-center pivotal trial (2017-2020) that substantiated NETSPOT’s diagnostic accuracy led to the widespread clinical adoption.
• Emerging trials focus on combining imaging with therapeutic agents (theranostics), particularly in affording precision medicine approaches.

Market Analysis of NETSPOT

Market Overview

Aspect	Data / Insights
Global Sales Revenue (2022)	~$300 million (Estimated)^[1^]
Major Market Regions	US (70%), Europe (20%), Asia-Pacific (10%)^[2^]
FDA Approval & Reimbursement	Widely reimbursed in US via Medicare/Medicaid; coverage expanding globally^[3^]
Key Competitors	Somatostatin receptor imaging agents: Octreoscan (old), Lutathera (therapeutic agent)

Market Drivers

• Increase in Diagnosis of Neuroendocrine Tumors: Rising incidence rates (e.g., US: 8.37 cases per 100,000 annually)^[4^].
• Advancements in Molecular Imaging: Demand for more precise, non-invasive detection tools.
• Approval for Expanded Indications: Potential label extensions for smaller, atypical, or pediatric tumors.

Market Barriers

Barrier	Impact
High Cost of Imaging	~$4,500 per scan; limits access in some regions
Limited Awareness	Among some clinicians, particularly in developing markets
Regulatory Variability	Approval status varies, affecting global rollout

Competitive Landscape

Agent	Type	Approval Status	Strengths	Limitations
NETSPOT	Gallium Ga 68 dotatate	FDA (2016), EMA (2018)	High sensitivity, specificity	Cost, limited access outside major centers
Octreoscan	Indium In-111 pentetreotide	Older, less sensitive	Well-established, reimbursement	Lower resolution, longer imaging times
Lutathera (Lu-177 DOTATATE)	Therapeutic	Approved (2018)	Therapeutic complement	Therapeutic-specific, not imaging

Market Projections (2023–2028)

Market Growth Drivers

• CAGR estimate of 8.2% (2023–2028), driven by increasing diagnosis and clinical adoption^[5^].
• Expected expansion in emerging markets, particularly in Asia-Pacific, as awareness and infrastructure improve.

Forecast Table: Revenue & Units

Year	Estimated Global Revenue (USD Millions)	Units of Scans (Thousands)	Key Notes
2023	$320	70	Recovery post-pandemic, expanding use
2024	$355	78	New indications, expanded access
2025	$390	86	Market penetration deepening
2026	$430	95	Introduction of theranostic protocols
2027	$470	105	Growth in pediatric and mixed indications
2028	$520	115	Fully emergent markets, sustained adoption

Note: All figures are estimates based on current market size, growth trends, and pipeline progression.

Comparison with Alternative Technologies

Table 1: Imaging Modalities for Neuroendocrine Tumors

Modality	Resolution	Sensitivity	Limitations	Regulatory Status
Ga-68 PET/CT (NETSPOT)	High	>90%	Cost, provider availability	FDA/EMA approved
In-111 Octreotide (Octreoscan)	Moderate	~75%	Longer imaging, lower resolution	Approved, but declining use
FDG-PET	Variable	Lower for well-differentiated NETs	Less specific	Widely available

Future Outlook and Opportunities

• Label Expansion: FDA and EMA may authorize NETSPOT for additional indications, including pediatric use and early-stage detection.
• Theranostic Integration: Combining NETSPOT with radionuclide therapy (e.g., Lutathera) to create comprehensive diagnostic-therapeutic pathways.
• Digital and AI Adoption: Leveraging AI for image analysis to improve interpretability and accuracy.
• Global Expansion: Emerging markets present significant growth potential, driven by rising incidence and healthcare investments.

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Key Takeaways

• Clinical Trial Status: Ongoing studies aim to broaden NETSPOT's utility, with notable focus on pediatric populations and expanded indications.
• Market Dynamics: The global market for NETSPOT is growing at an estimated CAGR of over 8%, supported by increased diagnosis and technological advancements.
• Competitive Position: Dominant in somatostatin receptor imaging, with ongoing innovations in theranostics.
• Growth Opportunities: Label extensions, market penetration in Asia-Pacific, and integration into theranostic regimens will drive future revenues.
• Challenges: High costs, reimbursement variability, and clinician awareness remain barriers to universal adoption.

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FAQs

Q1: What factors influence the clinical adoption of NETSPOT?
A1: Factors include diagnostic accuracy, reimbursement policies, physician awareness, availability of PET/CT infrastructure, and regulatory approvals.

Q2: How does NETSPOT compare to other somatostatin receptor imaging agents?
A2: NETSPOT offers higher resolution, sensitivity, and specificity compared to older agents like Octreoscan, facilitating earlier detection and accurate staging.

Q3: What are the prospects for expanding NETSPOT’s indications?
A3: Trials are exploring pediatric uses, tumor grading, and theranostic applications, which may lead to regulatory approvals expanding its label.

Q4: What is the potential global market size for NETSPOT by 2028?
A4: An estimated market size of over $520 million, driven by increased use and regional market expansion.

Q5: What are the main barriers to global adoption?
A5: Cost of the radiopharmaceuticals, limited access in low-resource settings, regulatory variance, and clinician awareness.

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References

1. "Gallium Ga-68 DOTATATE (NETSPOT) Market Size & Trends," Allied Market Research, 2022.
2. "Global Neuroendocrine Tumor Imaging Market," MarketsandMarkets, 2022.
3. Centers for Medicare & Medicaid Services (CMS), 2022, Reimbursement policies for nuclear medicine procedures.
4. Yao JC, et al. "Epidemiology of Neuroendocrine Tumors in the United States." JAMA Oncology, 2020.
5. Grand View Research, "Neuroendocrine Tumor Imaging Market Size & Share," 2022.

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Note: All projections and data points are based on current literature, industry reports, and ongoing clinical trial insights as of early 2023.