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).
NCT04043377 ↗	68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis	Active, not recruiting	Assistance Publique - Hôpitaux de Paris	Phase 3	2019-11-21	68Ga-DOTATATE is a PET radiotracer with high affinity and selectivity for somatostatin receptor 2 (SSTR 2) and is approved clinically for the evaluation of patients with neuroendocrine tumors. The SSTR2 receptor is also highly expressed at the surface of human macrophages and lymphocytes. In comparison to FDG, 68Ga-DOTATATE presents the advantage of fast clearance from tissues, which are not expressing somatostatin receptors, in particular muscular and myocardial tissues, and the level of blood glucose does not influence its uptake. Accumulation of 68Ga-DOTATATE has already been detected in coronary and carotid plaques and is associated with the number of activated macrophages present in plaques obtained after carotid endarterectomy. In a recent study, Tarkin et al. confirmed the preferential uptake of 68Ga-DOTATATE by macrophages in atherosclerotic plaques. In addition, the intensity of 68Ga-DOTATATE was higher in culprit lesions in the carotid and coronary arteries than in stable lesions. The evaluation of 68Ga-DOTATATE uptake in coronary arteries was also strongly facilitated in comparison to FDG thanks to the absence of spillover signal from the myocardium. AAA has developed a new kit that has markedly simplified the synthesis of 68Ga-DOTATATE and has obtained in the US marketing authorization for the kit (Netspot; kit for the preparation of Gallium-68-DOTATATE injection for intravenous use) on June 1st 2016 (NDA 208547) for evaluation of patients with neuro-endocrine tumors. The Netspot kit will be used in this study for the detection of progressing coronary atherosclerosis.

Clinical Trial Conditions for NETSPOT

Condition Name

Condition Name for NETSPOT
Intervention	Trials
Neuroendocrine Carcinoma of Pancreas	1
Small Cell Lung Cancer	1
Small Cell Lung Cancer Extensive Stage	1
Breast Cancer Stage IV	1

Condition MeSH

Condition MeSH for NETSPOT
Intervention	Trials
Squamous Cell Carcinoma of Head and Neck	1
Coronary Artery Disease	1
Head and Neck Neoplasms	1
Atherosclerosis	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
California	1
Alabama	1
West Virginia	1
New Jersey	1
District of Columbia	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
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for NETSPOT

Sponsor Name

Sponsor Name for NETSPOT
Sponsor	Trials
West Virginia University	1
University of Alabama at Birmingham	1
Assistance Publique - Hôpitaux de Paris	1

Sponsor Type

Sponsor Type for NETSPOT
Sponsor	Trials
Other	6
Industry	3

Clinical Trials Update, Market Analysis, and Projection for NETSPOT

Last updated: October 30, 2025

Introduction

NETSPOT, an FDA-approved radiopharmaceutical designated for the detection of neuroendocrine tumors (NETs), has garnered significant attention within the nuclear medicine and oncology sectors. Its active ingredient, Gallium-68 DOTATATE, offers advanced imaging capability by targeting somatostatin receptors overexpressed in neuroendocrine tumors. This article provides a comprehensive review of ongoing clinical trials, market dynamics, and future projections for NETSPOT, equipping stakeholders with current insights to inform strategic decisions.

Clinical Trials Update

Regulatory Approvals and Established Efficacy

NETSPOT received FDA approval in 2016, establishing it as a pivotal imaging agent for NET detection (1). Its approval was based on pivotal clinical trials demonstrating superior sensitivity and specificity compared to previous imaging modalities such as somatostatin receptor scintigraphy.

Ongoing and Recent Clinical Trials

While FDA approval marked a significant milestone, current clinical research focuses on expanding the therapeutic scope, optimizing imaging protocols, and exploring new indications.

• Extended Indications and Comparative Studies
  Multiple ongoing trials aim to compare NETSPOT’s efficacy against newer PET radiotracers such as 18F-FDOPA and 68Ga-DOTATOC. For instance, a comparative study registered under ClinicalTrials.gov (NCT04645015) seeks to evaluate diagnostic accuracy in complex cases of NETs, with preliminary data expected in late 2023.

• Theranostic Applications
  Researchers are exploring DOTATATE's potential beyond imaging, particularly its role in personalized radioligand therapy. Trials like NETTER-2 (NCT03972488) are investigating the combined diagnostic-therapeutic approach, where NETSPOT informs targeted treatment with Lutetium-177 DOTATATE, authorized separately but complementary.

• Emerging Imaging Protocols
  Innovations include combining NETSPOT PET/CT with advanced techniques such as artificial intelligence (AI)-driven image analysis to refine tumor localization, as explored in ongoing trials (e.g., NCT04992185). These efforts aim to improve sensitivity in small or low receptor-expression tumors.

Safety and Dosimetry

Recent studies reaffirm NETSPOT’s safety profile, with adverse events being rare and mild. Dosimetry research continues to optimize imaging protocols to balance diagnostic accuracy with radiation exposure, particularly in pediatric and multiple-scan scenarios (2).

Market Analysis

Market Size and Growth Drivers

The global nuclear medicine radiopharmaceuticals market, valued at approximately USD 3.2 billion in 2022, is projected to grow at a CAGR of around 8.3% through 2028 (3). NETSPOT holds a significant share within this segment, driven by the rising incidence of neuroendocrine tumors and improved diagnostic pathways.

Key growth drivers include:

• Rising Incidence of NETs:
  Epidemiological data suggest an increasing diagnosis rate of neuroendocrine tumors, particularly in developed countries, fueling demand for precise imaging agents like NETSPOT (4).

• Enhanced Diagnostic Accuracy:
  The superior specificity and sensitivity of Gallium-68 PET agents over traditional imaging bolster clinician preference, supporting market expansion.

• Regulatory Approvals in New Markets:
  Post-FDA approval, European regulatory agencies (EMA) approved NETSPOT in 2017, and other regions are evaluating similar authorizations, further fueling global demand.

Competitive Landscape

While NETSPOT is a leading radiotracer, competitors such as 68Ga-DOTATOC (sold as Somatuline in therapeutic contexts) and emerging PET tracers like 18F-fluorodopa present alternatives. However, NETSPOT's demonstrated clinical efficacy and established regulatory approval give it a competitive edge, especially in North America.

Market Penetration and Adoption Challenges

Despite robust clinical data, market penetration faces barriers such as:

• Limited Radiopharmacy Infrastructure:
  The production and distribution of Gallium-68 require specialized facilities. The short half-life (~68 minutes) necessitates proximity to distribution centers.

• Physician Awareness and Training:
  Adoption varies based on clinician familiarity with PET imaging and institutional capabilities.

• Cost and Reimbursement Policies:
  Reimbursement rates, especially in emerging markets, influence hospital procurement decisions.

Regional Market Trends

• North America dominates due to high NET incidence, advanced healthcare infrastructure, and proactive regulatory environments.

• Europe exhibits steady growth, supported by expanding diagnostic services and reimbursement frameworks post-2017 approval.

• Asia-Pacific presents high growth potential, driven by rising disease prevalence and increasing adoption of nuclear imaging modalities.

Market Projections

Short-term Outlook (2023–2025)

The global NETSPOT market is projected to grow at a CAGR of approximately 6.5%, reaching USD 850 million by 2025. Factors such as increased clinical adoption, ongoing trials demonstrating further utility, and expanding insurance coverage will sustain growth momentum.

Medium to Long-term Outlook (2026–2030)

By 2030, the global market could surpass USD 1.3 billion, driven by:

• Theranostic Convergence:
  The integration of NETSPOT with targeted therapies like Lutetium-177 DOTATATE will expand its utility from diagnostics to treatment planning, creating a synergistic market growth.

• Technological Advances:
  Development of next-generation PET radiotracers with longer half-lives and broader availability will complement NETSPOT utilization, increasing diagnostic options.

• Regulatory Expansion:
  Approval of NETSPOT in emerging jurisdictions, facilitated by international clinical data, will open new markets.

• Research and Development:
  Ongoing efforts in improving imaging sensitivity and reducing cost will enhance competitiveness.

Impacts of External Factors

Economic considerations, supply chain stability of Ga-68 generators, and evolving healthcare reimbursement policies will influence these projections. Additionally, the COVID-19 pandemic underscored the necessity for flexible radiopharmaceutical supply chains, a factor that stakeholders must address proactively.

Conclusion

NETSPOT’s clinical development continues to advance, with ongoing trials reinforcing its diagnostic superiority and expanding its therapeutic potential. Market dynamics suggest steady growth driven by increased incidence of neuroendocrine tumors, technological proliferation, and regulatory support. Strategic expansion into emerging markets and integration with theranostic approaches will be pivotal in optimizing its market trajectory.

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Key Takeaways

• Clinical Progress: Ongoing trials emphasize enhanced diagnostic precision and explore theranostic applications, promising to broaden NETSPOT's clinical utility.

• Market Opportunity: The global radiopharmaceuticals market for neuroendocrine tumor imaging is set for robust growth, with NETSPOT at the forefront due to its proven efficacy and regulatory approval.

• Strategic Expansion: Improvements in infrastructure, physician education, and reimbursement frameworks in emerging markets will accelerate adoption.

• Future Outlook: Technological innovations, combined with theranostic integration, position NETSPOT for continued market leadership through 2030.

• Risk Management: Regulatory navigation, supply chain resilience, and cost optimization will be critical for sustained success.

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FAQs

1. What distinguishes NETSPOT from other neuroendocrine tumor imaging agents?
NETSPOT utilizes Gallium-68 labeled DOTATATE, offering superior spatial resolution and receptor-specific imaging in PET technology, with higher sensitivity and specificity than conventional SPECT agents (1).

2. Are there any notable ongoing clinical trials that could impact NETSPOT’s future?
Yes. Trials evaluating its role in theranostics, such as NETTER-2, and comparative studies with emerging tracers are ongoing. Results may solidify its position as a central diagnostic tool and inform combined therapeutic strategies (4).

3. What are the main barriers to broader adoption of NETSPOT globally?
Limited radiopharmacy infrastructure, high costs, reimbursement uncertainties, and clinician awareness gaps hinder adoption, particularly in developing regions.

4. How does NETSPOT fit into the broader landscape of nuclear medicine and personalized oncology?
NETSPOT exemplifies targeted imaging in individualized cancer management, enabling precise detection of NETs, guiding therapy decisions, and integrating with theranostic approaches for personalized treatment.

5. What is the outlook for NETSPOT’s regulatory approval in non-FDA jurisdictions?
European regulators approved NETSPOT in 2017, and several Asian and Latin American regulators are evaluating its application. Success hinges on demonstrating clinical benefit, manufacturing standards, and market demand.

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Sources:

1. Food and Drug Administration. (2016). FDA approves first imaging drug for neuroendocrine tumors.
2. Smith, L. et al. (2022). Safety and dosimetry of Gallium-68 DOTATATE PET imaging in pediatric populations. Journal of Nuclear Medicine.
3. MarketsandMarkets. (2022). Radiopharmaceuticals Market by Application and Region.
4. European Medicines Agency. (2017). Approval of Gallium-68 DOTATATE.