CLINICAL TRIALS PROFILE FOR GALLIUM DOTATATE GA-68

All Clinical Trials for Gallium Dotatate Ga-68

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01873248 ↗	Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients	Completed	Jonsson Comprehensive Cancer Center	Phase 1/Phase 2	2013-08-26	This is a prospective, Phase 1-2, single center study in a total of 100 subjects with Neuroendocrine Tumors (NETs). Study participants will receive a one-time administration of 68Ga-DOTATATE and undergo a PET/CT imaging study, to investigate its suitability as a PET imaging agent for NETs.
NCT01967537 ↗	Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors	Completed	National Cancer Institute (NCI)	Phase 2	2013-10-18	Background: - Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The only treatment for NETs is surgery, but most are found when they are too advanced for surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can be successful. They want to test if the study drug can be used along with imaging devices to detect NETs. Objectives: - To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown primary and metastatic NETs in the gastrointestinal system and pancreas. Eligibility: - Adults over 10 years old with a suspected NET or family history of NET. Design: - Participants will be screened with a medical history and physical exam, and have a blood test. - Participants will undergo three scans. For all of these, a substance is injected into their body, they lie on a table, and a machine takes images. - A standard computed tomography (CT) scan of the chest, abdomen, and pelvis. - An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT. - A 68Gallium-DOTATATE positron emission tomography (PET)/CT. The study drug is injected into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device takes images of the body. The entire session takes 90 to 120 minutes. - Researchers will compare images from the three scans. - Participants will have 1 follow-up visit each year for 5 years. At this visit, they will have a medical exam, blood taken, and a CT scan.
NCT02078843 ↗	Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors	Terminated	SWAN Isotopen AG, Bern	Phase 1/Phase 2	2014-03-01	The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher diagnostic value in the detection of neuroendocrine tumors than the established imaging method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the investigators will compare the diagnostic performance of both methods.
NCT02078843 ↗	Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors	Terminated	University Hospital, Basel, Switzerland	Phase 1/Phase 2	2014-03-01	The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher diagnostic value in the detection of neuroendocrine tumors than the established imaging method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the investigators will compare the diagnostic performance of both methods.
NCT02078843 ↗	Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors	Terminated	University of Bern	Phase 1/Phase 2	2014-03-01	The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher diagnostic value in the detection of neuroendocrine tumors than the established imaging method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the investigators will compare the diagnostic performance of both methods.
NCT02078843 ↗	Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors	Terminated	University of Lausanne Hospitals	Phase 1/Phase 2	2014-03-01	The investigators hypothesize that the new imaging method Gallium-68-DOTATATE has a higher diagnostic value in the detection of neuroendocrine tumors than the established imaging method Indium-111-Octreoscan. Therefore, the investigators will perform both imaging procedures in patients with suspected or confirmed neuroendocrine tumors. Subsequently, the investigators will compare the diagnostic performance of both methods.

Clinical Trial Conditions for Gallium Dotatate Ga-68

Condition Name

Condition Name for Gallium Dotatate Ga-68
Intervention	Trials
Neuroendocrine Tumors	4
Neuroendocrine Neoplasm	2
Gastroenteropancreatic Neuroendocrine Tumors	2
Neuroendocrine Carcinoma	1

Condition MeSH

Condition MeSH for Gallium Dotatate Ga-68
Intervention	Trials
Neuroendocrine Tumors	11
Carcinoid Tumor	6
Pancreatic Neoplasms	3
Carcinoma	2

Clinical Trial Locations for Gallium Dotatate Ga-68

Trials by Country

Trials by Country for Gallium Dotatate Ga-68
Location	Trials
United States	21
France	2
China	2
Canada	1
Switzerland	1

Trials by US State

Trials by US State for Gallium Dotatate Ga-68
Location	Trials
California	4
Maryland	3
Minnesota	3
Kentucky	2
Alabama	1

Clinical Trial Progress for Gallium Dotatate Ga-68

Clinical Trial Phase

Clinical Trial Phase for Gallium Dotatate Ga-68
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Gallium Dotatate Ga-68
Clinical Trial Phase	Trials
Recruiting	10
Active, not recruiting	2
Completed	2

Clinical Trial Sponsors for Gallium Dotatate Ga-68

Sponsor Name

Sponsor Name for Gallium Dotatate Ga-68
Sponsor	Trials
National Cancer Institute (NCI)	7
Jonsson Comprehensive Cancer Center	2
Mayo Clinic	2

Sponsor Type

Sponsor Type for Gallium Dotatate Ga-68
Sponsor	Trials
Other	17
NIH	8

Gallium-68 Dotatate: Clinical Trials, Market Analysis, and Projections

Introduction to Gallium-68 Dotatate

Gallium-68 dotatate, a radiopharmaceutical, has gained significant attention in the medical field, particularly in the diagnosis and management of neuroendocrine tumors (NETs). This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Trial Design and Objectives

The clinical trials for gallium-68 dotatate, including Ga 68 dotatate and Ga 68 dotatoc, were designed to evaluate the safety and efficacy of these radiopharmaceuticals in detecting NETs.

• Trial A: This trial involved 97 adult patients with known or suspected NETs. The images obtained from gallium Ga 68 dotatate PET scans were compared to CT, MRI, and SPECT images using indium In 111 pentetreotide. The results showed that gallium Ga 68 dotatate PET was in agreement with CT and/or MR images in 74 out of 78 patients where these images were available[1].

• Trial B: This trial included 104 patients with suspected NETs. Gallium Ga 68 dotatate PET correctly identified the NET site in 29 out of 36 patients confirmed to have NETs by CT, MRI, and SPECT. It was falsely negative in 7 out of 36 patients and falsely positive in 7 out of 68 patients where no NET was identified by other imaging techniques[1].

• Trial C: This trial focused on patients with known NETs to evaluate tumor recurrence. Gallium Ga 68 dotatate PET correctly located the tumor in 23 out of 29 patients with recurrence and showed no tumor recurrence in 29 out of 34 patients without recurrence[1].

Efficacy and Accuracy

The trials demonstrated high accuracy for gallium-68 dotatate in detecting NETs.

• In Trial B, the positive percent agreement for reader 1 was 92% and for reader 2 was 90%, while the negative percent agreement was 75% for both readers[4].

• The trials also highlighted the superiority of gallium-68 dotatate over other imaging techniques in certain cases, particularly in identifying small tumors and those in challenging anatomical locations[1][4].

Safety Profile

The safety of gallium-68 dotatate was evaluated in several trials, involving a total of 334 patients.

• Adverse reactions were minimal, with gastrointestinal disorders such as nausea occurring in less than 2% of patients. Skin and subcutaneous tissue disorders like pruritus and vascular disorders like flushing were reported in less than 1% of patients[4].

Market Analysis

Current Market Value and Growth Projections

The global gallium-68 market, which includes gallium-68 dotatate, was valued at approximately $100 million in 2020. It is projected to expand at a compound annual growth rate (CAGR) of about 8% from 2021 to 2031, reaching around $200 million by 2031[2][5].

Regional Market Dynamics

• North America: This region is expected to dominate the global gallium-68 market due to increased access to healthcare, rapid adoption of advanced PET systems, and a high prevalence of NETs. Over 12,000 people in the U.S. are diagnosed with NETs each year, driving the demand for gallium-68 radiopharmaceuticals[2][5].

• Europe: The European market is also anticipated to grow significantly, driven by the increasing use of gallium-68 radiopharmaceuticals in diagnosing diseases related to cardiology, respiratory, and urology[2][5].

• Asia Pacific: This region is expected to expand rapidly due to improvements in healthcare infrastructure, increased incidence of neurological disorders, and growing research and development activities[2][5].

Application Segmentation

The oncology segment, particularly the diagnosis and management of NETs and prostate cancer, dominates the gallium-68 market. Other applications include neurology, cardiology, and urology, which are also expected to contribute to market growth[2][5].

Key Drivers and Challenges

Drivers

• Increasing Prevalence of Cancer: The rise in cancer cases globally, especially NETs, is a significant driver for the gallium-68 market[2][5].

• Advancements in Nuclear Medicine: Improvements in PET imaging technologies and the introduction of new radiopharmaceuticals have enhanced the diagnostic capabilities of gallium-68 dotatate[2][5].

• Government Policies and Reimbursement: New reimbursement policies by governments have made these treatments more accessible, boosting market growth[2].

Challenges

• Regulatory Approvals: While gallium-68 dotatate has been approved by regulatory bodies like the FDA, ongoing regulatory scrutiny and the need for continuous clinical evidence can pose challenges[1][4].

• Competition: The market is competitive, with several key players such as Siemens Healthineers AG, ITM Isotopen Technologien München AG, and Advanced Accelerator Applications (a Novartis AG Company)[5].

Future Projections and Opportunities

Emerging Applications

• Neurotheranostics: Gallium-68 dotatate is being explored for its role in neurotheranostics, particularly in planning therapy for brain tumors like meningiomas and high-grade gliomas[3].

• New Radiopharmaceuticals: Research on new 68Ga-labeled tracers for various therapeutic applications and nuclear imaging is expected to create new opportunities for the global gallium-68 market[5].

Market Expansion Strategies

• Inorganic Growth: Key players are adopting inorganic growth strategies, such as mergers and acquisitions, to expand their market presence and boost the global gallium-68 market[5].

• Geographical Expansion: Major businesses are planning to invest and expand in developing economies like China and India, where there is a growing demand for advanced healthcare technologies[5].

Key Takeaways

• Clinical Efficacy: Gallium-68 dotatate has shown high accuracy and efficacy in detecting NETs in clinical trials.
• Market Growth: The global gallium-68 market is projected to grow at a CAGR of about 8% from 2021 to 2031.
• Regional Dominance: North America is expected to dominate the market, while Asia Pacific is anticipated to offer significant growth opportunities.
• Emerging Applications: New applications in neurotheranostics and the development of new radiopharmaceuticals are expected to drive future growth.

FAQs

Q: What is the primary use of gallium-68 dotatate in clinical practice?

A: The primary use of gallium-68 dotatate is in the diagnosis and management of neuroendocrine tumors (NETs) using positron emission tomography (PET) imaging.

Q: What were the key findings from the clinical trials of gallium-68 dotatate?

A: The clinical trials showed high accuracy and efficacy of gallium-68 dotatate in detecting NETs, with positive percent agreements ranging from 90% to 92% and negative percent agreements of 75%[1][4].

Q: What is the projected growth rate of the global gallium-68 market?

A: The global gallium-68 market is projected to expand at a CAGR of about 8% from 2021 to 2031[2][5].

Q: Which region is expected to dominate the gallium-68 market?

A: North America is expected to dominate the global gallium-68 market due to increased access to healthcare and the high prevalence of NETs[2][5].

Q: What are the emerging applications of gallium-68 dotatate?

A: Emerging applications include neurotheranostics, particularly in planning therapy for brain tumors, and the development of new 68Ga-labeled tracers for various therapeutic and diagnostic uses[3][5].

Sources

1. FDA: Drug Trials Snapshot: Netspot - FDA.
2. BioSpace: Gallium-68 Market: Enhanced Research on Applications ... - BioSpace.
3. MDPI: The Role of [68Ga]Ga-DOTA-SSTR PET Radiotracers in Brain Tumors.
4. FDA: Drug Trials Snapshots: Ga-68-DOTATOC - FDA.
5. Transparency Market Research: Gallium-68 Market Survey Report 2031.