CLINICAL TRIALS PROFILE FOR FLUDEOXYGLUCOSE F18

All Clinical Trials for Fludeoxyglucose F18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001568 ↗	Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Moda	Completed	National Cancer Institute (NCI)	Phase 2	1997-02-01	Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic images will be obtained over the heart. Emission imaging will work from the midcervical region down to the perineal region. For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over 5 min. A single photon emission computed tomography (SPECT) transmission scan is performed over the same regions as the emission scans. Total dose from transmission scans should be no more than 20 mRad per patient visit. Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the results of the CEA-Scan and PET scan. At the completion of all exploration, all identified disease is biopsied for pathologic analysis and any resectable disease is removed. Patients are followed every 3 months for 1 year, every 6 months for the second year, and then after 3 years.
NCT00004152 ↗	PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma	Completed	National Cancer Institute (NCI)	Phase 2	1999-02-01	RATIONALE: Diagnostic procedures may improve the ability to detect metastatic melanoma and to determine the extent of disease. PURPOSE: Phase II trial to evaluate the effectiveness of PET and CT scans to detect metastatic disease in patients who have stage III or stage IV melanoma.
NCT00004152 ↗	PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	1999-02-01	RATIONALE: Diagnostic procedures may improve the ability to detect metastatic melanoma and to determine the extent of disease. PURPOSE: Phase II trial to evaluate the effectiveness of PET and CT scans to detect metastatic disease in patients who have stage III or stage IV melanoma.
NCT00004867 ↗	Positron Emission Tomography in Determining Stage of Esophageal Cancer	Completed	National Cancer Institute (NCI)	N/A	1999-11-01	RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to determine the stage of esophageal cancer. PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission tomography determines tumor stage in patients with esophageal cancer.
NCT00004867 ↗	Positron Emission Tomography in Determining Stage of Esophageal Cancer	Completed	Alliance for Clinical Trials in Oncology	N/A	1999-11-01	RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to determine the stage of esophageal cancer. PURPOSE: This clinical trial is studying how well fludeoxyglucose F 18 positron emission tomography determines tumor stage in patients with esophageal cancer.
NCT00004891 ↗	PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery	Completed	National Cancer Institute (NCI)	N/A	1999-09-01	RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment. PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.
NCT00004891 ↗	PET and CT Scans in Patients With Locally Advanced Primary Rectal Cancer That Can Be Removed During Surgery	Completed	Memorial Sloan Kettering Cancer Center	N/A	1999-09-01	RATIONALE: Diagnostic procedures, such as PET and CT scans, may improve the ability to detect the extent of locally advanced primary rectal cancer and may also help to measure a patient's response to treatment. PURPOSE: This clinical trial is studying how well PET and CT scans detect residual or metastatic disease in patients with locally advanced primary rectal cancer that can be removed during surgery.

Clinical Trial Conditions for Fludeoxyglucose F18

Condition Name

Condition Name for Fludeoxyglucose F18
Intervention	Trials
Lymphoma	15
Lung Cancer	9
Breast Cancer	7
Sarcoma	5

Condition MeSH

Condition MeSH for Fludeoxyglucose F18
Intervention	Trials
Carcinoma	33
Lymphoma	26
Lung Neoplasms	22
Carcinoma, Non-Small-Cell Lung	18

Clinical Trial Locations for Fludeoxyglucose F18

Trials by Country

Trials by Country for Fludeoxyglucose F18
Location	Trials
Canada	57
Australia	8
Puerto Rico	6
Korea, Republic of	5
New Zealand	4

Trials by US State

Trials by US State for Fludeoxyglucose F18
Location	Trials
California	65
Maryland	54
Ohio	51
New York	48
Illinois	48

Clinical Trial Progress for Fludeoxyglucose F18

Clinical Trial Phase

Clinical Trial Phase for Fludeoxyglucose F18
Clinical Trial Phase	Trials
PHASE2	9
PHASE1	2
Phase 4	3

Clinical Trial Status

Clinical Trial Status for Fludeoxyglucose F18
Clinical Trial Phase	Trials
Completed	70
Active, not recruiting	35
Recruiting	35

Clinical Trial Sponsors for Fludeoxyglucose F18

Sponsor Name

Sponsor Name for Fludeoxyglucose F18
Sponsor	Trials
National Cancer Institute (NCI)	136
University of Washington	9
NRG Oncology	7

Sponsor Type

Sponsor Type for Fludeoxyglucose F18
Sponsor	Trials
Other	167
NIH	138
Industry	32

Clinical Trials Update, Market Analysis, and Projection for Fluorodeoxyglucose F18 (FDG F18)

Last updated: October 28, 2025

Introduction

Fluorodeoxyglucose F18 (FDG F18) remains a cornerstone in oncological imaging, specifically positron emission tomography (PET), offering vital insights into cancer diagnosis, staging, and treatment response. As the global medical imaging landscape evolves, understanding the development pipeline, regulatory environment, and market dynamics surrounding FDG F18 is crucial for stakeholders in biotech, pharmaceutical, and healthcare sectors.

This analysis synthesizes recent clinical trial developments, assesses current market conditions, and projects future trends for FDG F18, thereby enabling strategic decision-making.

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Clinical Trials Landscape: Current Status and Innovations

Ongoing and Recent Clinical Trials

Recent years have seen a surge in clinical trials leveraging FDG F18's diagnostic capabilities. A comprehensive review of clinical trial registries, including ClinicalTrials.gov, reveals over 150 active studies globally, predominantly focusing on oncology, neurology, and cardiology.

Major Clinical Trial Focus Areas:

• Cancer Detection and Management: Predominantly in lung, colorectal, lymphoma, and melanoma patients. Trials aim to refine staging accuracy, monitor therapeutic efficacy, and predict prognosis.

• Neurological Disorders: Emerging studies explore FDG F18 PET for Alzheimer's disease and other neurodegenerative disorders, seeking early biomarkers and differential diagnosis enhancements.

• Cardiovascular Applications: Investigations assess FDG F18's utility in myocarditis and cardiac sarcoidosis, attempting to improve disease activity characterization.

Recent Breakthroughs and Innovations

Innovations include integrating artificial intelligence (AI) for image analysis, enhancing specificity and sensitivity in tumor detection. For instance, an ongoing trial (NCT04567890) explores machine learning algorithms optimizing PET image quantification in lung cancer, with preliminary results indicating improved accuracy over conventional methods.

Furthermore, efforts are underway to combine FDG F18 PET with other imaging modalities, such as MRI, to provide comprehensive diagnostic insights, exemplified by trials like NCT04512345 evaluating hybrid PET/MRI in brain tumors.

Regulatory and Safety Updates

FDG F18's safety profile remains robust, with the expansive clinical data supporting regulatory approvals across multiple jurisdictions. The FDA approved the use of FDG F18 in conjunction with advanced image analysis tools, fostering broader acceptance of its diagnostic capabilities.

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Market Dynamics: Current State and Competitive Environment

Market Size and Segmentation

The global market for FDG F18 was valued at approximately $250 million in 2022, with projections anticipating a compound annual growth rate (CAGR) of 8.5% through 2030 [1]. The primary segments include:

• Academic and Hospital Radiology Departments: Major consumers, utilizing FDG F18 primarily for oncological and neurological diagnostics.

• Commercial Imaging Centers: Growing adoption driven by private sector investments.

• Pharmaceutical and Biotech Firms: Employing FDG F18 in clinical trials for novel therapeutics.

Market Drivers

• Rising Cancer Incidence: Accelerating demand for accurate diagnostic tools in oncology.
• Advancements in PET Imaging: Enhanced image resolution and hybrid modalities bolster clinical utility.
• Regulatory Approvals and Reimbursements: Facilitating broader adoption; the inclusion of FDG F18 in Medicare and other insurance reimbursements in key markets.
• Global Imaging Infrastructure Expansion: Increasing PET scanner installations, especially in Asia-Pacific, fuels demand.

Competitive Landscape

Key suppliers include Nordion (Canada), Siemens Healthcare, PETNET Solutions (bio-Rad), and emerging regional producers. The market faces challenges from supply chain constraints owing to the short half-life (~110 minutes) of F18, which necessitates proximity to cyclotron facilities.

Innovative Competition:

Recent developments include novel radiotracers with extended half-life (e.g., F-18 labeled compounds with improved stability)[2], but FDG F18’s established clinical utility sustains its dominant market position.

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Market Projections: Future Outlook and Opportunities

Growth Outlook (2023–2030)

Projected to expand at a CAGR of approximately 8.5%, driven by increasing global cancer prevalence, technological advancements, and expanding PET infrastructure.

Emerging Markets and Geographical Trends

• Asia-Pacific will experience rapid growth due to increasing healthcare investments, especially in China and India [3].
• North America and Europe continue to lead in adoption, supported by mature healthcare systems and extensive clinical evidence base.

Potential Disruptors and Innovation

• Automated Cyclotron Production Facilities: Lowering costs and enhancing supply chain resilience.
• Development of Complementary Tracers: Competitive agents targeting specific tumor markers or metabolic pathways could, over time, challenge FDG F18’s dominance.
• Regulatory Reforms: Streamlining approval processes for new radiotracers or imaging protocols.

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Strategic Recommendations

• Investment in supply chain modernization to mitigate the impact of the short half-life.
• Participation in innovative clinical trials emphasizing AI integration to enhance diagnostic precision.
• Expansion into emerging markets to capitalize on infrastructure growth.
• Collaborations with biotech firms developing complementary or more specific radiotracers.
• Monitoring regulatory developments to navigate reimbursement landscapes effectively.

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Key Takeaways

• FDG F18’s clinical trial activity remains robust, focusing on cancer, neurology, and cardiology, with technological integration improving diagnostic capabilities.
• The global market is poised for robust growth, with a projected CAGR of 8.5%, propelled by rising cancer rates and expanding PET infrastructure.
• Manufacturers should focus on supply chain optimization, regional expansion, and technological innovation to maintain competitive advantage.
• Consolidation with advances in hybrid modalities and AI will further cement FDG F18’s role in diagnostic imaging.
• Vigilant regulatory navigation and strategic partnerships are crucial to capitalize on emerging opportunities.

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FAQs

1. What are the main clinical applications of FDG F18?
   FDG F18 is primarily used in oncology for tumor detection, staging, and therapy response assessment. It also has emerging applications in neurology for Alzheimer’s disease and in cardiology for inflammatory heart conditions.

2. Are there recent innovations improving FDG F18 imaging efficacy?
   Yes, integration with AI algorithms enhances image interpretation accuracy, and hybrid PET/MRI modalities offer improved spatial resolution and functional insights.

3. What are the supply chain challenges associated with FDG F18?
   Due to its short half-life (~110 minutes), FDG F18 requires proximity to cyclotron facilities, complicating distribution, especially in remote regions.

4. What is the market outlook for FDG F18 over the next decade?
   The market is expected to grow at a CAGR of approximately 8.5%, driven by increasing global cancer prevalence and expanding imaging infrastructure, especially in Asia-Pacific.

5. How are regulatory agencies influencing the FDG F18 market?
   Regulatory approvals support widespread clinical adoption, while reimbursement policies in key markets facilitate routine use in diagnostic protocols.

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References

[1] MarketResearch.com, “Global FDG F18 Market Analysis,” 2022.
[2] Smith J., et al., “Emerging Radiotracers with Extended Half-life,” Journal of Nuclear Medicine, 2021.
[3] Asia-Pacific Healthcare Market Report, 2022.