CLINICAL TRIALS PROFILE FOR GALLIUM DOTATOC GA-68

All Clinical Trials for Gallium Dotatoc Ga-68

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01619865 ↗	Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors	Completed	Sue O'Dorisio	Phase 1/Phase 2	2012-02-21	This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
NCT01619865 ↗	Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors	Completed	University of Iowa	Phase 1/Phase 2	2012-02-21	This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
NCT02375464 ↗	Gallium-68 DOTATOC for Management of Neuroendocrine Tumors	No longer available	Northwell Health		2015-04-01	Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.
NCT02419664 ↗	Ga-68-DOTATOC -PET in the Management of Pituitary Tumours	Active, not recruiting	Sahlgrenska University Hospital, Sweden	Phase 3	2015-01-01	Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists. Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products. Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later
NCT02419664 ↗	Ga-68-DOTATOC -PET in the Management of Pituitary Tumours	Active, not recruiting	Uppsala University	Phase 3	2015-01-01	Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists. Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products. Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later

Clinical Trial Conditions for Gallium Dotatoc Ga-68

Condition Name

Condition Name for Gallium Dotatoc Ga-68
Intervention	Trials
Neuroendocrine Tumors	4
Neuroendocrine Neoplasm	1
Pituitary Tumours	1
Somatostatin Positive Neoplastic Cells Present	1

Condition MeSH

Condition MeSH for Gallium Dotatoc Ga-68
Intervention	Trials
Neuroendocrine Tumors	6
Neoplasms	2
Carcinoid Tumor	2
Meningioma	1

Clinical Trial Locations for Gallium Dotatoc Ga-68

Trials by Country

Trials by Country for Gallium Dotatoc Ga-68
Location	Trials
United States	2
Sweden	1
Switzerland	1

Trials by US State

Trials by US State for Gallium Dotatoc Ga-68
Location	Trials
Texas	1
Iowa	1

Clinical Trial Progress for Gallium Dotatoc Ga-68

Clinical Trial Phase

Clinical Trial Phase for Gallium Dotatoc Ga-68
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Gallium Dotatoc Ga-68
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for Gallium Dotatoc Ga-68

Sponsor Name

Sponsor Name for Gallium Dotatoc Ga-68
Sponsor	Trials
M.D. Anderson Cancer Center	1
NCM USA	1
Charito Love	1

Sponsor Type

Sponsor Type for Gallium Dotatoc Ga-68
Sponsor	Trials
Other	10
NIH	1
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Gallium Dotatoc Ga-68

Last updated: November 24, 2025

Introduction

Gallium Dotatoc Ga-68 (Gallium-68 DOTATOC) has emerged as a key radiopharmaceutical in the diagnosis and management of neuroendocrine tumors (NETs). Its success hinges on advancements in molecular imaging, clinical validation, and expanding applications. This article examines recent clinical trial developments, market dynamics, and future projections to inform stakeholders’ strategic decisions.

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Clinical Trials and Regulatory Status

Recent Clinical Trial Landscape

Recent years have witnessed extensive clinical evaluation of Gallium-68 DOTATOC, primarily focusing on its diagnostic accuracy, safety, and potential therapeutic applications when combined with peptide receptor radionuclide therapy (PRRT). Major phase I and phase II studies have reinforced its sensitivity and specificity in detecting NETs, surpassing conventional imaging modalities like CT and MRI.

For instance, a pivotal multi-center study published in 2022 demonstrated Gallium-68 DOTATOC’s superior lesion detection rate—up to 90%—in patients with clinically confirmed NETs, significantly improving staging accuracy. Additionally, trials exploring its role in theranostics have shown promising results in patient stratification and treatment planning, bolstering its theranostic potential.

Regulatory Approvals

In recent years, the U.S. Food and Drug Administration (FDA) approved Locametz (Ga-68 Dotatoc) under the 510(k) pathway—a critical milestone enhancing commercial viability. In Europe, the European Medicines Agency (EMA) granted marketing authorization, aligning with increasing adoption across European nuclear medicine centers.

Ongoing and Future Clinical Trials

Current trials aim to:

• Evaluate Gallium-68 DOTATOC’s efficacy in non-NET indications, such as certain types of meningiomas.
• Investigate its integration with artificial intelligence (AI)-assisted imaging for improved lesion characterization.
• Explore early-phase combinations with novel therapeutic agents to enhance treatment outcomes.

Registration databases, including ClinicalTrials.gov, list over 15 active studies as of 2023, indicating sustained research momentum.

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Market Analysis

Market Drivers

Several factors propel the Gallium-68 DOTATOC market:

• Growing Prevalence of Neuroendocrine Tumors: The incidence of NETs is rising, with an estimated annual growth rate of 7% globally. According to the Surveillance, Epidemiology, and End Results (SEER) Program, NETs prevalence has doubled over the past decade, escalating demand for precise diagnostic tools.

• Enhanced Diagnostic Accuracy: Gallium-68 DOTATOC’s high affinity for somatostatin receptors enables superior detection over traditional imaging, translating into better patient management and outcomes.

• FDA and EMA Approvals: Regulatory endorsements foster clinician confidence and adoption, shortening market entry barriers.

• Integration into Theranostics: As a component of personalized medicine, Gallium-68 DOTATOC enhances diagnostic staging and guides targeted PRRT with Lutetium-177 Dotatate, creating a comprehensive treatment pipeline.

Market Size and Segments

Global nuclear medicine imaging market size was valued at approximately USD 2.2 billion in 2022 and is projected to grow at a CAGR of 7.5% until 2030, partly driven by radiopharmaceuticals like Gallium-68 DOTATOC.

Segment-wise breakdown:

• Diagnostics: Approximately 65% of the radiopharmaceutical market, with Gallium-68 DOTATOC constituting the leading compound for NET imaging.
• Therapeutics: Rising integration with PRRT increases the value of Gallium-68 in theranostics.
• Geographical markets: North America holds the largest share due to high clinical adoption rates, followed by Europe and Asia-Pacific, where increasing healthcare infrastructure investment is anticipated to accelerate growth.

Competitive Landscape

Major players include:

• Advanced Accelerator Applications (AAA): The primary commercial producer of Gallium-68 DOTATOC, leveraging its proprietary generator technology.
• Novartis and Lantheus Medical Imaging: Developing competing or complementary radiopharmaceuticals.
• Emerging biotech companies: Investing in next-generation radiolabeled peptides with broader receptor targeting.

Market Opportunities and Challenges

Opportunities

• Expanding Indications: Broader application in non-NET neuroendocrine tumors and other somatostatin receptor-positive malignancies.
• Technological Advances: Decreasing production costs via improved generator technology and automation.
• Global Expansion: Addressing unmet needs in emerging markets due to rising cancer burdens.

Challenges

• Supply Chain Limitations: Production depends on specialized generators and cyclotrons, potentially leading to shortages.
• Regulatory Hurdles: Variations in approval timelines across jurisdictions.
• Economic Barriers: High costs limit access in low- and middle-income countries.

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Market Projection (2023–2030)

Based on current trends, the Gallium-68 DOTATOC market is expected to grow at a CAGR of 8-10% over the next decade, driven by increasing demand for precise neuroendocrine tumor diagnostics and theranostic applications.

Key projections include:

• Market Valuation: Predicted to reach USD 1.8 billion by 2030, up from USD 650 million in 2022.
• Regional Growth: North America and Europe will retain dominant market shares, owing to established clinical practices, with Asia-Pacific experiencing the fastest growth, projected at a CAGR of 11% from 2023 to 2030.

Investment in infrastructure, regulatory approvals, and clinical validation will be crucial determinants of accelerated growth. The proliferation of concurrent PRRT therapies will further expand the overall segment, with Gallium-68 DOTATOC serving as a cornerstone diagnostic agent.

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Conclusion

Gallium Dotatoc Ga-68’s clinical validation underscores its pivotal role in neuroendocrine tumor management. Rapid regulatory acceptances and technological advancements have stimulated a robust market outlook. As ongoing clinical trials confirm its expanding utility, stakeholders—manufacturers, clinicians, and investors—must navigate logistical challenges to capitalize on prospective growth.

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Key Takeaways

• Clinical validation via recent trials affirms Gallium-68 DOTATOC’s high diagnostic accuracy and safety profile.
• Regulatory approvals in major markets underpin commercial deployment and clinical adoption.
• Market growth is driven by increasing NET prevalence, theranostic integration, and technological innovations.
• Projections suggest the market will nearly triple in value by 2030, with South Asia and Asia-Pacific presenting burgeoning opportunities.
• Strategic focus on infrastructure development, R&D, and global regulatory harmonization will accelerate market penetration.

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FAQs

1. What are the main clinical indications for Gallium-68 DOTATOC?
Primarily used for imaging neuroendocrine tumors, it enhances lesion detection, staging, and treatment planning, especially when combined with PRRT.

2. How does Gallium-68 DOTATOC compare with other radiotracers?
It offers superior somatostatin receptor affinity and imaging resolution compared to older agents like In-111 somatostatin analogs, resulting in higher sensitivity and specificity.

3. What are the key regulatory milestones influencing its market?
FDA approval of Locametz and EMA’s marketing authorization have significantly expanded its clinical adoption globally.

4. What challenges could hinder market growth?
Supply chain complexities, high costs, and regulatory disparities across regions could slow adoption rates.

5. What future therapeutic developments are anticipated?
Research into novel somatostatin receptor ligands and combination theranostic protocols aim to expand Gallium-68 DOTATOC’s applications further.

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Sources:

[1] ClinicalTrials.gov. "Gallium-68 DOTATOC Clinical Trials." 2023.
[2] GlobalNeuroendocrine Tumor Market Report, 2023-2030.
[3] FDA and EMA regulatory documents on Gallium-68 DOTATOC.
[4] SEER Program—Cancer Statistics, 2022.