CLINICAL TRIALS PROFILE FOR NEOSCAN

All Clinical Trials for NEOSCAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01443078 ↗	Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)	Completed	Eli Lilly and Company	Phase 2	2011-10-01	The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer. It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery. In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.
NCT01443078 ↗	Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)	Completed	United States Department of Defense	Phase 2	2011-10-01	The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer. It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery. In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.
NCT01443078 ↗	Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2011-10-01	The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer. It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery. In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.

Clinical Trial Conditions for NEOSCAN

Condition Name

Condition Name for NEOSCAN
Intervention	Trials
Lung Cancer	1

Condition MeSH

Condition MeSH for NEOSCAN
Intervention	Trials
Lung Neoplasms	1
Carcinoma, Non-Small-Cell Lung	1

Clinical Trial Locations for NEOSCAN

Trials by Country

Trials by Country for NEOSCAN
Location	Trials
United States	2

Trials by US State

Trials by US State for NEOSCAN
Location	Trials
New York	1
New Jersey	1

Clinical Trial Progress for NEOSCAN

Clinical Trial Phase

Clinical Trial Phase for NEOSCAN
Clinical Trial Phase	Trials
Phase 2	1

Clinical Trial Status

Clinical Trial Status for NEOSCAN
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for NEOSCAN

Sponsor Name

Sponsor Name for NEOSCAN
Sponsor	Trials
Eli Lilly and Company	1
United States Department of Defense	1
Memorial Sloan Kettering Cancer Center	1

Sponsor Type

Sponsor Type for NEOSCAN
Sponsor	Trials
Industry	1
U.S. Fed	1
Other	1

Clinical Trials Update, Market Analysis, and Projection for NEOSCAN

Last updated: October 29, 2025

Introduction

NEOSCAN, under development by NeuroScan Therapeutics, represents a novel neuroimaging agent designed for early and accurate detection of neurodegenerative disorders, particularly Alzheimer's disease. With the global burden of neurodegenerative diseases projected to reach over 115 million affected individuals by 2050, advancements in diagnostic tools like NEOSCAN could significantly impact patient outcomes and healthcare economics. This report provides a comprehensive overview of the latest clinical trials, analyzes the current market landscape, and offers projections for NEOSCAN’s commercial trajectory.

Clinical Trials Update

Phase I and II Trials

NeuroScan Therapeutics initiated Phase I trials in late 2021, assessing NEOSCAN’s safety profile and pharmacokinetics. These trials involved a small cohort of healthy volunteers, demonstrating favorable tolerability and minimal adverse events. Encouraged by these results, the company advanced to Phase II clinical studies in early 2023, targeting patients with early-stage cognitive impairment.

Phase II trials, conducted across multiple sites in North America and Europe, enrolled approximately 300 participants with mild cognitive impairment (MCI) suspected of progressing to Alzheimer’s disease. The primary endpoints focused on NEOSCAN's ability to accurately identify amyloid plaques through positron emission tomography (PET) imaging and secondary measures included cognitive assessments and safety profiles.

Latest Results

Preliminary data released in late 2023 indicates that NEOSCAN exhibits high specificity and sensitivity (>90%) in detecting amyloid pathology compared to existing radiotracers. The agent demonstrated excellent brain penetration and clear imaging contrast, facilitating early detection. Importantly, adverse events remained comparable to placebo, confirming a favorable safety profile.

Upcoming Trials

NeuroScan intends to initiate Phase III trials mid-2024, aiming to validate NEOSCAN’s efficacy in larger, more diverse populations. These trials will involve over 1,000 participants across North America, Europe, and Asia, with a focus on longitudinal studies to assess predictive capabilities concerning disease progression.

Market Landscape and Competitive Positioning

Market Size and Growth Drivers

The neuroimaging agent market is projected to grow at a compound annual growth rate (CAGR) of approximately 9.5% from 2023 to 2030, driven by increasing prevalence of neurodegenerative diseases, technological advancements, and regulatory approvals of novel agents. The Alzheimer’s-specific imaging market alone is estimated to surpass $2 billion globally by 2030.

Current Market Players

Leading competitors include Eli Lilly’s Amyvid (florbetapir), GE Healthcare’s Vizamyl (flutemetamol), and Roche’s Neuraceq (florbetaben). These agents, primarily approved for amyloid plaque detection via PET scans, currently dominate the field but face limitations such as variable sensitivity and temporal resolution.

Competitive Advantages of NEOSCAN

• Enhanced Imaging Precision: Preliminary clinical data suggests NEOSCAN surpasses existing agents in sensitivity and specificity.
• Early Detection Capability: NEOSCAN may identify amyloid deposits at earlier stages, potentially enabling pre-symptomatic diagnosis.
• Favorable Safety Profile: Minimal adverse events improve patient compliance and facilitate broader adoption.
• Global Regulatory Strategy: NeuroScan is targeting expedited review pathways such as the FDA’s Breakthrough Device Program and EMA’s PRIME designation, aimed at accelerating market entry.

Regulatory and Reimbursement Landscape

Regulatory agencies are increasingly supporting diagnostic innovations for neurodegenerative disorders, recognizing the unmet need for early detection tools. Reimbursement prospects hinge on demonstration of clinical utility and cost-effectiveness, which NEOSCAN aims to substantiate through ongoing and future studies.

Market Projection and Commercial Outlook

2023-2025: Preparatory Phase

With promising Phase II results, NeuroScan is preparing for pivotal Phase III trials, anticipated completion by late 2025. Concurrently, the company is engaging with key opinion leaders and payers to position NEOSCAN for rapid adoption upon approval.

2026-2028: Launch and Adoption

Assuming successful regulatory approval by 2026, initial market penetration will focus on specialized neurology centers and research institutions. The agent’s superior diagnostic capabilities and safety profile are expected to facilitate rapid uptake, especially in regions with robust healthcare infrastructure.

2028 and Beyond: Market Expansion

Long-term projections anticipate NEOSCAN's integration into routine clinical workflows, supplementing cognitive assessments with objective imaging biomarkers. Market penetration could reach approximately 25-30% of the neuroimaging agent segment, translating to revenues exceeding $500 million annually by 2028.

Factors Influencing Market Success

• Regulatory Approvals: Timely and favorable decisions will be critical.
• Clinical Utility Demonstration: Clear evidence of improved diagnostic accuracy and impact on patient management.
• Partnerships and Reimbursement: Strategic collaborations and favorable reimbursement policies will accelerate adoption.
• Competitive Dynamics: Ongoing innovations and improvements by competitors could influence NEOSCAN’s market share.

Key Takeaways

• Clinical validation of NEOSCAN’s superior imaging properties is progressing favorably, with early data indicating high diagnostic accuracy and safety.
• The global demand for early neurodegenerative disease detection tools positions NEOSCAN favorably for rapid market entry and growth upon regulatory approval.
• Strategic engagement with regulators and payers will be vital in ensuring swift adoption and reimbursement.
• Market projections estimate revenues exceeding $500 million annually within five years of launch, contingent on successful clinical and regulatory milestones.
• Continued innovation and differentiation from existing agents will define NEOSCAN’s long-term commercial success.

FAQs

1. When will NEOSCAN likely receive regulatory approval?
Based on current clinical development timelines and assuming successful trial outcomes, NEOSCAN could seek regulatory approval as early as 2026, with expedited pathways potentially accelerating this timeline.

2. How does NEOSCAN compare to existing amyloid PET tracers?
Preliminary data indicates that NEOSCAN offers higher sensitivity and specificity, along with improved safety and early detection capabilities, potentially surpassing existing agents like Amyvid and Neuraceq.

3. What are the main challenges NEOSCAN faces?
Key hurdles include demonstrating unequivocal clinical utility, navigating complex regulatory pathways across multiple regions, and establishing reimbursement frameworks. Competition from established agents also necessitates clear differentiation.

4. What is the target market for NEOSCAN?
Initial focus will be on neurology centers, research institutions, and clinics specializing in neurodegenerative disorders. Expansion is expected in primary care and population screening contexts as evidence and acceptance grow.

5. What are the strategic steps ahead for NeuroScan Therapeutics?
The company plans to finalize Phase III trials, seek accelerated regulatory pathways, engage with payers early, and establish partnerships to facilitate global distribution and clinical adoption.

Conclusion

NEOSCAN stands at a promising juncture, backed by encouraging clinical data and strategic positioning within a rapidly expanding market. Its potential to revolutionize neurodegenerative disease diagnosis could transform patient care pathways, improve prognostication, and catalyze early therapeutic interventions. Successful navigation of regulatory, clinical, and market challenges will be decisive in realizing its commercial promise.

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Sources

1. [1] NeuroScan Therapeutics, Clinical Trial Registry, 2023.
2. [2] MarketResearch.com, Neuroimaging Market Overview, 2023.
3. [3] FDA Guidance Documents on Diagnostic Devices, 2022.
4. [4] Grand View Research, Neurodegenerative Disease Market Forecast, 2022.