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
Plasma Cell Myeloma	5

Condition MeSH

Condition MeSH for FLUDEOXYGLUCOSE F18
Intervention	Trials
Carcinoma	32
Lymphoma	26
Lung Neoplasms	21
Sarcoma	17

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	60
Maryland	53
Ohio	49
New York	45
Illinois	45

Clinical Trial Progress for FLUDEOXYGLUCOSE F18

Clinical Trial Phase

Clinical Trial Phase for FLUDEOXYGLUCOSE F18
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	16
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for FLUDEOXYGLUCOSE F18
Clinical Trial Phase	Trials
Completed	70
Active, not recruiting	35
Recruiting	27

Clinical Trial Sponsors for FLUDEOXYGLUCOSE F18

Sponsor Name

Sponsor Name for FLUDEOXYGLUCOSE F18
Sponsor	Trials
National Cancer Institute (NCI)	129
University of Washington	8
NRG Oncology	7

Sponsor Type

Sponsor Type for FLUDEOXYGLUCOSE F18
Sponsor	Trials
Other	155
NIH	131
Industry	27

FLUDEOXYGLUCOSE F18 Market Analysis and Financial Projection

Fludeoxyglucose F18 (FDG): Clinical Trials, Market Analysis, and Projections

Introduction

Fludeoxyglucose F18 (FDG) is a radioactive tracer that acts as a glucose analog, widely used in positron emission tomography (PET) scans for diagnostic purposes. This article will delve into the current clinical trials, market analysis, and future projections for FDG.

Clinical Trials and Applications

Evaluation of Malignancy

FDG PET/CT is well-established for cancer detection and monitoring response to therapy. Clinical trials have consistently shown its effectiveness in determining abnormal glucose metabolism, which is crucial for evaluating malignancy. For instance, the FDA review of F-18 FDG PET imaging highlights its use in assessing malignancy by comparing it to a "truth" standard, such as pathology results[3].

Combined F-18 NaF and F-18 FDG PET/CT

A notable clinical trial involves the combined administration of F-18 NaF and F-18 FDG in a single PET/CT scan. This study aims to determine the best approach for cancer detection and improve cancer treatment. The trial, led by Professor Andrei Iagaru at Stanford, explores the potential benefits of using both tracers to enhance diagnostic accuracy[1].

Non-Oncologic Applications

Beyond oncology, FDG PET/CT is used in various non-oncologic specialties such as cardiology, neurology, and cognitive neuroscience. It helps in diagnosing conditions like epilepsy, myocardial ischemia, and Alzheimer's disease by visualizing altered glucose metabolism in affected tissues[4][5].

Market Analysis

Market Size and Growth

The global fluorine-18 market, driven largely by FDG, was valued at approximately US$ 1.4 billion in 2020. It is projected to reach US$ 3 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.4% to 7.5% from 2021 to 2030[2][4].

Segmentation

The market is segmented by product, end-user, and region. The FDG segment is expected to dominate the market due to its high demand in oncology. Hospitals are the major end-users, with a significant increase in the demand for PET/CT machines in new hospital projects globally[2][4].

Regional Analysis

North America currently dominates the global fluorine-18 market, followed by Europe. However, the Asia Pacific region is expected to grow at a high CAGR due to increasing demand for health testing and the expansion of local players in countries like China and India[2][4].

Market Drivers

Increasing Demand for PET/CT Scans

The rising prevalence of diseases such as cancer, Alzheimer’s, and cardiovascular diseases is driving the demand for more precise diagnostic tools like PET/CT scans. This has led to an increased need for fluorine-18 isotopes, particularly FDG[2][4].

COVID-19 Impact

During the COVID-19 pandemic, FDG PET/CT was suggested as a non-invasive method for detecting infectious or inflammatory diseases. This has further boosted the demand for fluorine-18, despite the initial disruptions in production and distribution[2].

Technological Advancements

Combined PET/CT scanners have significantly improved diagnostic accuracy by pinpointing abnormal metabolic activity more precisely than separate PET and CT scans. This technological advancement is a major factor driving the demand for fluorine-18[4].

Market Challenges

High Setup Costs

One of the significant challenges facing the fluorine-18 market is the high setup cost for PET/CT systems, which can be prohibitive for smaller healthcare facilities and regions. Manufacturers are working to make these devices more affordable to address this issue[2][4].

Key Players

Major players in the global fluorine-18 market include Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare (General Electric Company), and Blue Earth Diagnostics (A Bracco Imaging Company)[2].

Future Projections

Expanding Clinical Applications

The use of FDG PET/CT is expected to expand beyond oncology into more non-oncologic specialties. This diversification will continue to drive the demand for fluorine-18 isotopes[4].

Geographic Expansion

The Asia Pacific region, particularly countries like India and China, will offer significant growth opportunities due to the rising demand for health testing and the increasing installation of new PET/CT machines in hospitals[2][4].

Technological Innovations

Ongoing technological innovations in PET/CT scanners and the development of more affordable devices will further propel the market growth. These advancements will make PET/CT scans more accessible and cost-effective, leading to increased adoption in various healthcare settings[4].

Key Takeaways

• Clinical Trials: FDG continues to be a crucial tool in clinical trials for cancer detection and other conditions, with ongoing studies exploring its combined use with other tracers.
• Market Growth: The global fluorine-18 market is projected to grow significantly, driven by the increasing demand for PET/CT scans and expanding clinical applications.
• Regional Expansion: The Asia Pacific region is expected to be a key growth area due to rising health awareness and increasing healthcare infrastructure.
• Technological Advancements: Combined PET/CT scanners and efforts to make these devices more affordable will continue to drive market growth.

FAQs

What is the primary use of Fludeoxyglucose F18 (FDG) in medical imaging?

FDG is primarily used as a glucose analog in positron emission tomography (PET) scans to diagnose and monitor various conditions, particularly cancer, by visualizing altered glucose metabolism.

How is the global fluorine-18 market expected to grow?

The global fluorine-18 market is projected to grow at a CAGR of 7.4% to 7.5% from 2021 to 2030, reaching a valuation of around US$ 3 billion by 2030.

What are the main drivers of the fluorine-18 market?

The main drivers include the increasing demand for PET/CT scans in oncology and other specialties, the impact of COVID-19 on diagnostic needs, and technological advancements in PET/CT scanners.

Which regions are expected to see significant growth in the fluorine-18 market?

North America currently dominates the market, but the Asia Pacific region is expected to grow at a high CAGR due to increasing demand and healthcare infrastructure development.

What are the challenges facing the fluorine-18 market?

One of the significant challenges is the high setup cost for PET/CT systems, which can be prohibitive for smaller healthcare facilities and regions.

Who are the key players in the global fluorine-18 market?

Key players include Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare (General Electric Company), and Blue Earth Diagnostics (A Bracco Imaging Company).

Sources

1. Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy - Stanford University Clinical Trials.
2. Fluorine-18 Market Insight and Trends 2031 - Transparency Market Research.
3. Review of F-18 Fluoro-2-Deoxyglucose (F-18 FDG) Positron Emission Tomography (PET) Evaluation of Malignancy - FDA.
4. Fluorine-18 Market Size Worth Around US$ 3 Billion by 2030 - BioSpace.
5. Fludeoxyglucose F18 - StatPearls - NCBI Bookshelf.