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	3
Neuroblastoma	1
Neuroendocrine Neoplasm	1
Pituitary Tumours	1

Condition MeSH

Condition MeSH for Gallium Dotatoc Ga 68
Intervention	Trials
Neuroendocrine Tumors	5
Carcinoid Tumor	2
Neoplasms	2
Pituitary Neoplasms	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

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
Phase 3	3
Phase 1/Phase 2	1
Early Phase 1	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
Sue O'Dorisio	1
University of Iowa	1
Northwell Health	1

Sponsor Type

Sponsor Type for Gallium Dotatoc Ga 68
Sponsor	Trials
Other	9
NIH	1
Industry	1

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

Last updated: January 9, 2025

Introduction to Gallium-68 DOTATOC

Gallium-68 DOTATOC is a radiopharmaceutical used in positron emission tomography (PET) scans to identify and diagnose neuroendocrine tumors (NETs). This drug has been clinically used in Europe for over a decade and is now on the path to broader availability in the United States.

Clinical Trials and Efficacy

The efficacy of Gallium-68 DOTATOC has been established through several clinical trials. In 2019, the FDA approved Ga-68 DOTATOC for the detection of somatostatin receptor-positive NETs based on findings from three clinical trials (NCT1619865, NCT1869725, and NCT2441062), which enrolled 334 patients with known or suspected NETs. These trials showed that Ga-68-DOTATOC successfully identified NETs approximately 90% to 92% of the time[1][3].

In another clinical trial, patients received Gallium Ga 68-DOTA-TOC intravenously, followed by a PET/CT or PET/MRI scan. The primary objective was to determine if Ga-68 DOTA-TOC results in the delineation of more lesions than conventional imaging. Secondary objectives included assessing whether the incorporation of Ga-68 DOTA-TOC PET/CT into management decision-making changes the patient's stage[4].

Safety and Adverse Effects

While Gallium-68 DOTATOC has shown high efficacy, it is a radioactive drug, which may increase the risk of lifetime radiation exposure. Common adverse effects include nausea, itching, and flushing[1][3].

FDA Approval and Availability

Evergreen Theragnostics, Inc. has submitted a New Drug Application (NDA) for EVG-001, a kit for the preparation of Gallium-68 DOTATOC injection, to the U.S. FDA. The FDA has accepted this application and set a target action date of July 20, 2023. If approved, doses prepared using EVG-001 are expected to be available starting in the third quarter of 2023, making Ga-68 DOTATOC imaging available nationwide for NET patients in an easy-to-use kit for radiopharmacies[1][3].

Market Analysis

Global Market Value and Growth

The global gallium-68 market was valued at approximately US$ 100 million in 2020 and is projected to expand at a compound annual growth rate (CAGR) of about 8% from 2021 to 2031. By 2030, the market is expected to reach US$ 200 million[2][5].

Regional Market Dynamics

North America is anticipated to account for a significant share of the global gallium-68 market, driven by increased access to healthcare and the rapid introduction of advanced technological implementations in PET systems. Europe is also expected to see high growth due to the increasing use of gallium-68 radiopharmaceuticals in diagnosing diseases related to cardiology, respiratory, and urology. The Asia Pacific region is projected to expand rapidly due to improvements in healthcare infrastructure, an increase in neurological disorders, and surge in research and development activities[2].

Growth Strategies of Key Players

Evergreen Theragnostics, a US-based radiopharmaceutical company, is playing a crucial role in expanding the availability of Gallium-68 DOTATOC. The company's submission of the NDA for EVG-001 represents its first NDA and is a significant step in broadening its portfolio of offerings. Evergreen Theragnostics specializes in CDMO services and the commercialization of theragnostic radiopharmaceuticals, with a state-of-the-art global GMP facility in New Jersey[3].

Applications and Future Prospects

Diagnostic Imaging Applications

Gallium-68 is widely used in PET imaging for various applications, including prostate cancer imaging (68Ga-PSMA) and neuroendocrine tumors (68Ga-peptides such as DOTA-TATE, DOTA-TOC, and DOTA-NOC). The isotope's short half-life of 68 minutes and good radiation properties make it ideal for labeling small molecules and peptides for diverse diagnostic applications[2].

Therapeutic Applications

There is ongoing research into the therapeutic applications of gallium-68, including the development of new 68Ga-labeled tracers for nuclear imaging and potential therapeutic uses. These advancements are expected to create new opportunities and drive the global gallium-68 market during the forecast period[5].

Conclusion

Gallium-68 DOTATOC is a highly effective radiopharmaceutical for the imaging of neuroendocrine tumors. With its high efficacy rates and pending FDA approval for broader availability, it is set to make a significant impact on the diagnosis and management of NETs in the United States.

Key Takeaways

• Clinical Efficacy: Gallium-68 DOTATOC has shown high efficacy in identifying NETs, with success rates of 90% to 92% in clinical trials.
• FDA Approval: The FDA has accepted the NDA for EVG-001, with a target action date of July 20, 2023, and expected availability in Q3 2023.
• Market Growth: The global gallium-68 market is projected to grow at a CAGR of 8% from 2021 to 2031, reaching US$ 200 million by 2030.
• Regional Dynamics: North America, Europe, and the Asia Pacific are key regions driving market growth due to advancements in healthcare and research.
• Future Prospects: Ongoing research into new applications and therapeutic uses of gallium-68 is expected to further propel the market.

FAQs

Q: What is Gallium-68 DOTATOC used for?

A: Gallium-68 DOTATOC is used in positron emission tomography (PET) scans to identify and diagnose neuroendocrine tumors (NETs).

Q: What are the common adverse effects of Gallium-68 DOTATOC?

A: Common adverse effects include nausea, itching, and flushing, along with the potential risk of increased lifetime radiation exposure.

Q: What is the current status of FDA approval for Gallium-68 DOTATOC?

A: The FDA has accepted the New Drug Application (NDA) for EVG-001, with a target action date of July 20, 2023.

Q: How is the global gallium-68 market expected to grow?

A: The global gallium-68 market is projected to expand at a CAGR of about 8% from 2021 to 2031, reaching US$ 200 million by 2030.

Q: What regions are driving the growth of the gallium-68 market?

A: North America, Europe, and the Asia Pacific are key regions driving market growth due to advancements in healthcare and research.

Sources

1. FDA Accepts New Drug Application for the Radiopharmaceutical Imaging Kit EVG-001 for NETs. Onclive.
2. Gallium-68 Market: Enhanced Research on Applications of Gallium-68 Reveals New Opportunities. BioSpace.
3. Evergreen Theragnostics Submits New Drug Application for Gallium-68 DOTATOC Kit with US FDA. PR Newswire.
4. GA-68 DOTA-TOC of Somatostatin Positive Malignancies. Network of Care.
5. Gallium-68 Market to grow at a CAGR of 8% from 2021 to 2030. BioSpace.