CLINICAL TRIALS PROFILE FOR FLUDEOXYGLUCOSE F-18

All Clinical Trials for FLUDEOXYGLUCOSE F-18

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.

Clinical Trial Conditions for FLUDEOXYGLUCOSE F-18

Condition Name

Condition Name for FLUDEOXYGLUCOSE F-18
Intervention	Trials
Lymphoma	15
Lung Cancer	9
Breast Cancer	7
Sarcoma	5

Condition MeSH

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

Clinical Trial Locations for FLUDEOXYGLUCOSE F-18

Trials by Country

Trials by Country for FLUDEOXYGLUCOSE F-18
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 F-18
Location	Trials
California	65
Maryland	54
Ohio	51
New York	48
Illinois	48

Clinical Trial Progress for FLUDEOXYGLUCOSE F-18

Clinical Trial Phase

Clinical Trial Phase for FLUDEOXYGLUCOSE F-18
Clinical Trial Phase	Trials
PHASE2	9
PHASE1	2
Phase 4	3

Clinical Trial Status

Clinical Trial Status for FLUDEOXYGLUCOSE F-18
Clinical Trial Phase	Trials
Completed	70
Active, not recruiting	35
Recruiting	35

Clinical Trial Sponsors for FLUDEOXYGLUCOSE F-18

Sponsor Name

Sponsor Name for FLUDEOXYGLUCOSE F-18
Sponsor	Trials
National Cancer Institute (NCI)	136
University of Washington	9
NRG Oncology	7

Sponsor Type

Sponsor Type for FLUDEOXYGLUCOSE F-18
Sponsor	Trials
Other	167
NIH	138
Industry	32

Clinical Trials Update, Market Analysis, and Projection for Fludeoxyglucose F-18

Last updated: October 28, 2025

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Introduction

Fludeoxyglucose F-18 (FDG) remains the cornerstone radiopharmaceutical in oncological, neurological, and cardiac imaging. As a glucose analog labeled with Fluorine-18, FDG's pivotal role in positron emission tomography (PET) scans makes it indispensable for disease diagnosis, staging, and treatment monitoring. The evolving landscape of molecular imaging, advancements in radiochemistry, and regulatory focuses necessitate a thorough analysis of FDG’s ongoing clinical development, market dynamics, and future projections.

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Clinical Trials Landscape for Fludeoxyglucose F-18

Current Status and Trends

FDG's familiarity and proven efficacy in oncology underpin most approved indications; however, the scope of clinical research is expanding to include novel applications and complementary biomarkers. As of 2023, over 150 clinical trials globally focus on FDG PET imaging, with a prominent concentration in oncology, neurology, and cardiology.

Most ongoing studies aim to optimize imaging protocols, reduce radiation doses, and evaluate FDG in emerging cancer types such as immunotherapy-responsive tumors. Statistically, Phase II and III trials dominate, emphasizing a trend toward consolidating FDG’s utility rather than developing new radiotracers from scratch.

Emerging Clinical Focus

• Immunotherapy Monitoring: Several studies examine FDG PET's precision in assessing immune response, notably in therapies targeting PD-1/PD-L1 pathways. These trials seek to refine response criteria, distinguish pseudoprogression, and guide personalized therapy adjustment.

• Neurological Disorders: Increasing trials explore FDG in neurodegenerative diseases, such as Alzheimer’s disease, aiming to enhance early detection, differentiate subtypes, and monitor therapeutic efficacy.

• Radiopharmaceutical Innovations: Efforts are underway to develop dual-modality imaging agents combining FDG with other tracers, such as amino acid analogs, to improve tumor characterization.

Regulatory and Development Challenges

While FDG remains FDA-approved and widely adopted, clinical research faces hurdles including supply chain complexities, radiation safety concerns, and the quest for more specificity amid competition from novel tracers such as PSMA ligands in prostate cancer.

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Market Analysis

Market Size and Growth Trajectory

The global FDG PET radiopharmaceutical market was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7-9% through 2030 [1]. The increasing prevalence of cancers, expanding indications, and advancements in PET imaging technology propel this growth.

Market Drivers

• Oncology Dominance: Accounting for roughly 75% of the FDG market, oncology remains the primary driver, with lung, colorectal, and lymphoma cancers leading demand.

• Expanding Non-Oncological Applications: Rising use in neurology and cardiology adds to expanding market segments.

• Technological Enhancements: The proliferation of hybrid PET/CT and PET/MRI systems enhances diagnostic accuracy, encouraging more frequent FDG PET utilization.

• Regulatory Approvals and Reimbursement: Reimbursements by Medicare and private insurers in major markets like the U.S. support regular clinical adoption.

Market Constraints

• Supply Chain and Production Constraints: FDG’s short half-life (~110 minutes) mandates nearby cyclotron facilities, limiting distribution. This creates regional supply disparities.

• Emerging Alternatives: Newer tracers with higher specificity, such as PSMA or FLT, threaten to encroach on FDG's market share, especially in niche indications.

• Cost and Accessibility: High operational costs and limited availability of radiopharmacies restrict widespread adoption in emerging markets.

Competitive Landscape

Key players include Cardinal Health, GE Healthcare, Siemens Healthineers, and Jubilant Radiopharma. Their investments focus on optimizing production, expanding markets, and integrating digital health solutions.

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Market Projection and Future Outlook

Growth Factors

• Clinical Validation: As ongoing trials solidify FDG’s role in immunotherapy response and early diagnosis, clinical confidence will buoy demand.

• Infrastructure Development: Investment in regional radiopharmacies and cyclotron networks, especially in Asia-Pacific, will extend access.

• Regulatory Milestones: Streamlined approval pathways for new delivery platforms and dose optimization technologies will facilitate market expansion.

Risks and Opportunities

• Risks: Introduction of more selective tracers, regulatory restrictions due to radiation safety concerns, and geopolitical issues affecting supply chains.

• Opportunities: Integration with AI-driven image analysis, expansion into emerging markets, and development of hybrid or multi-modal tracers.

Projection Summary

By 2030, the FDG PET radiopharmaceutical market is expected to exceed USD 2 billion, driven by technological innovation, expanding clinical indications, and infrastructural expansion, especially within emerging economies. The CAGR is anticipated to stabilize around 8%, reflecting saturation in core markets alongside growth in ancillary applications.

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Key Takeaways

• Continuous clinical trials reinforce FDG’s vital role in oncology and burgeoning applications in neurology and cardiology.

• Market growth is sustained by rising cancer incidence, technological advancements, and infrastructural investments, with Asia-Pacific poised as a significant growth hub.

• Supply chain limitations and competition from newer tracers remain challenges, though regulatory support and expanding clinical utility present robust growth opportunities.

• Strategic partnerships and innovation in delivery methods, such as generator-based systems, will be crucial for accessible and cost-effective FDG marketing.

• Ongoing research and trial outcomes will shape future indications, potentially broadening FDG’s clinical utility and market penetration.

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FAQs

1. What are the primary clinical applications of Fludeoxyglucose F-18?
FDG is primarily used in oncology for tumor detection, staging, and treatment response assessment. It also plays a vital role in neurology for diagnosing neurodegenerative diseases and in cardiology for evaluating myocardial viability.

2. How do supply chain challenges affect the FDG market?
FDG’s short half-life demands on-site cyclotron production or nearby radiopharmacies. This creates logistical hurdles, limiting distribution scope, especially in remote regions, and constrains market growth potential.

3. What emerging clinical indications are gaining attention for FDG PET imaging?
Research focuses on immunotherapy response assessment, early detection of neurodegenerative disorders, and evaluating treatment efficacy in novel cancer types, expanding FDG’s clinical footprint.

4. How does competition from alternative tracers impact FDG’s market?
New tracers targeting specific tumor markers (e.g., PSMA) and molecular pathways introduce niche competition, potentially reducing FDG’s dominance in certain indications but not its overall established utility.

5. What is the outlook for FDG PET radiopharmaceuticals over the next decade?
The outlook is optimistic, with continuous clinical validation and technological enhancements expected to sustain growth, broaden applications, and improve accessibility globally.

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References

[1] Global Market Insights. (2022). Radiopharmaceuticals Market Size and Trends.
[2] Society of Nuclear Medicine and Molecular Imaging. (2023). Clinical Trials on FDG PET Imaging.
[3] Allied Market Research. (2023). Positron Emission Tomography Market by Modality, Application, and End-user.
[4] U.S. Food and Drug Administration. (2022). Regulatory Approvals and Guidance on Radiopharmaceuticals.