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

Clinical Trial Conditions for Gallium Dotatoc Ga-68

Condition Name

Condition Name for Gallium Dotatoc Ga-68
Intervention	Trials
Neuroendocrine Tumors	3
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	5
Neoplasms	2
Carcinoid Tumor	2
Neuroblastoma	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
National Cancer Institute (NCI)	1
M.D. Anderson Cancer Center	1
NCM USA	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

Introduction to Gallium-68 DOTATOC

Gallium-68 DOTATOC is a radiopharmaceutical used in positron emission tomography (PET) scans to detect somatostatin receptor positive neuroendocrine tumors (NETs). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and FDA Approval

The FDA approved Ga-68 DOTATOC on August 21, 2019, based on evidence from three clinical trials (Trials 1, 2, and 3) that enrolled 334 patients with known or suspected NETs[1][4].

Trial Outcomes

• Efficacy: In Trials 1 and 2, Ga-68 DOTATOC correctly identified NETs approximately 90-92% of the time. The positive and negative percent agreements were high, indicating the drug's effectiveness in detecting NETs[4].
• Safety: The safety of Ga-68 DOTATOC was evaluated in these trials, with common adverse reactions including nausea, itching, and flushing, all occurring at rates of less than 2%[4].

Recent Developments

• A new drug application (NDA) for EVG-001, a kit for the preparation of Gallium-68 DOTATOC injection, has been accepted by the FDA. This kit is expected to make Ga-68 DOTATOC imaging more widely available in the U.S., with a target action date set for July 20, 2023[1].

Market Analysis

Global Market Size and Growth

The global gallium-68 market, which includes Ga-68 DOTATOC, was valued at approximately $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 $200 million[2][5].

Regional Market Dynamics

• North America: This region is expected to account for a significant share of the global gallium-68 market due to the high prevalence of neuroendocrine tumors and the increasing access to advanced healthcare technologies[2].
• Europe: The market in Europe is also anticipated to grow rapidly, 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 projected to expand at a rapid pace due to improvements in healthcare infrastructure, an increase in neurological disorders, and surge in research and development activities[2].

Key Drivers

• Increasing Prevalence of Cancer: The rise in cancer cases, particularly neuroendocrine tumors, is a major driver for the gallium-68 market. Over 12,000 people in the U.S. are diagnosed with NETs each year[2].
• Advancements in Nuclear Medicine: The sensitivity and specificity of gallium-68 radiopharmaceuticals, along with advancements in PET systems, are propelling the market forward[2][5].

Applications and Future Prospects

Diagnostic Applications

• Neuroendocrine Tumors: Ga-68 DOTATOC is primarily used for imaging somatostatin receptor positive NETs. Its high accuracy in detecting these tumors makes it a valuable diagnostic tool[1][4].
• Other Tumors: Besides NETs, gallium-68 based tracers like DOTATATE and DOTANOC are being explored for other tumors, including prostate cancer and brain tumors[3].

Therapeutic Applications

• Neurotheranostics: Gallium-68 DOTATOC is also being evaluated for planning neurotheranostics therapy, particularly for assessing SSTR2 expression and eligibility for [177Lu]Lu-DOTATATE therapy in recurrent meningiomas and pituitary carcinomas[3].

Research and Development

• Ongoing research is focused on exploring new applications of gallium-68, including various therapeutic uses and new tracer developments. This ongoing innovation is expected to further drive the market[5].

Safety and Side Effects

Ga-68 DOTATOC, being a radioactive drug, may increase the risk of lifetime radiation exposure. Common adverse reactions include nausea, itching, and flushing, which occur at relatively low rates[1][4].

Key Takeaways

• Clinical Trials: Ga-68 DOTATOC has shown high efficacy in detecting NETs in clinical trials, with approval from the FDA in 2019.
• Market Growth: The global gallium-68 market is projected to grow at a CAGR of 8% from 2021 to 2031, driven by increasing cancer prevalence and advancements in nuclear medicine.
• Regional Dynamics: North America, Europe, and Asia Pacific are key regions driving the market growth.
• Future Prospects: Ongoing research and new applications in diagnostic and therapeutic fields are expected to further expand the market.

FAQs

Q: What is Ga-68 DOTATOC used for?

A: Ga-68 DOTATOC is used for the detection of somatostatin receptor positive neuroendocrine tumors (NETs) using positron emission tomography (PET) scans.

Q: What were the outcomes of the clinical trials for Ga-68 DOTATOC?

A: The clinical trials showed that Ga-68 DOTATOC correctly identified NETs approximately 90-92% of the time, with high positive and negative percent agreements.

Q: What are the common side effects of Ga-68 DOTATOC?

A: Common adverse reactions include nausea, itching, and flushing, occurring at rates of less than 2%.

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

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

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

A: North America, Europe, and Asia Pacific are the key regions driving the market growth due to various factors including high cancer prevalence and advancements in healthcare technologies.

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. The Role of [68Ga]Ga-DOTA-SSTR PET Radiotracers in Brain Tumors - MDPI
4. Drug Trials Snapshots: Ga-68-DOTATOC - FDA
5. Gallium-68 Market to grow at a CAGR of 8% from 2021 to 2030 - BioSpace