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	19

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	66
Maryland	54
Ohio	51
Illinois	48
New York	48

Clinical Trial Progress for FLUDEOXYGLUCOSE F18

Clinical Trial Phase

Clinical Trial Phase for FLUDEOXYGLUCOSE F18
Clinical Trial Phase	Trials
PHASE2	10
PHASE1	3
Phase 4	3

Clinical Trial Status

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

Clinical Trial Sponsors for FLUDEOXYGLUCOSE F18

Sponsor Name

Sponsor Name for FLUDEOXYGLUCOSE F18
Sponsor	Trials
National Cancer Institute (NCI)	138
University of Washington	9
Alliance for Clinical Trials in Oncology	8

Sponsor Type

Sponsor Type for FLUDEOXYGLUCOSE F18
Sponsor	Trials
Other	169
NIH	140
Industry	32

Fluorodeoxyglucose F 18 (Fludeoxyglucose F 18): Clinical Trial Update, Market Analysis, and Supply-Chain-Led Projections

Last updated: April 25, 2026

What is Fludeoxyglucose F 18 and how is it used in clinical practice?

Fludeoxyglucose F 18 (FDG F 18) is a radiopharmaceutical used for positron emission tomography (PET) imaging. In routine oncology and cardiology workflows, it supports metabolic imaging through uptake of glucose analog in tissues. FDG F 18 is a cornerstone product within PET imaging supply chains because it is used at scale across major indications and care settings.

Key operational points for market modeling:

• Product format: PET radiotracer, administered for imaging after radiochemical preparation and quality release.
• Distribution constraint: time and logistics driven by short half-life (radiochemistry and same-day/near-term regional distribution).
• Provider dependence: throughput depends on availability, regulatory release, generator/production capacity (depending on the production model), and PET center scheduling.

What does the clinical trials pipeline look like?

A complete, indication-by-indication clinical trials update requires a live registry pull and a defined cutoff date. No such trial-state feed (e.g., ClinicalTrials.gov or EU CTR) is provided in the prompt, and the request is not scoped to specific trial identifiers, sponsor programs, or jurisdictions. With no registry data included, a complete and accurate “clinical trials update” cannot be produced without introducing uncontrolled assumptions.

What is the current market structure for FDG F 18?

FDG F 18 market structure is supply-chain and regulatory-release driven rather than discovery-driven. Demand is anchored by:

• The installed base of PET/CT and PET/MR scanners.
• The utilization rate of PET across oncology staging, restaging, and treatment response workflows.
• Imaging center cadence and radiotracer scheduling constraints due to radionuclide decay.

Market economics are shaped by:

• Fixed costs of radiochemical production and quality systems.
• Fragmented regional supply, because production and distribution are constrained by radionuclide half-life and local regulatory requirements.
• Tendering and preferred-provider contracting by imaging networks and hospital groups.

How is FDG F 18 priced and contracted?

FDG F 18 pricing is typically set via regulated or commercially contracted reimbursement environments, with the cash economics determined by:

• Number of scans performed per center (volume-driven).
• Local reimbursement and payer mix.
• Radiotracer procurement terms, including delivery frequency and cold-chain handling requirements.
• Quality release and compliance requirements that affect lot acceptance and schedule.

Because FDG F 18 is not a typical patent-led small-molecule “drug market,” price and volume move with utilization rather than with incremental innovation. Competitive advantage often comes from reliable supply, lot acceptance, and center-level logistics.

What are the market drivers for FDG F 18?

The demand case is supported by structural PET utilization growth:

• Continued uptake of PET imaging in oncology pathways (staging and monitoring).
• Increasing use in broader tumor types where PET impacts clinical decision-making.
• PET center network expansion in many regions, constrained mainly by scanner installations and staffing rather than radiotracer availability.

The single biggest operational driver is reliable supply continuity. Production interruptions directly impact schedule fulfillment at PET sites because missed slots cannot be backfilled easily.

What are the supply constraints that matter for projections?

FDG F 18 projections depend on production and delivery capacity rather than late-stage clinical endpoints.

Modeling constraints to anchor projections:

• Radiochemical production is time-sensitive and quality-gated.
• Distribution must fit radionuclide half-life windows.
• Regulatory release and batch disposition must clear on schedule.
• Regional availability is shaped by the location and capacity of suppliers who can meet same-day delivery.

Where supply is tight, utilization can become supply-constrained, shifting volumes from scheduled administrations to delayed slots or alternative modalities.

How should revenue and volume be projected?

A production-driven projection framework is appropriate for FDG F 18 because:

• Demand is tied to clinical utilization of PET imaging services.
• Supply reliability determines whether booked demand converts to administered doses.

A practical projection approach:

1. Estimate PET dose utilization growth (driven by scan counts and scanner utilization).
2. Convert dose utilization into radiotracer demand in “administered dose-equivalents” per region.
3. Apply procurement elasticity based on local supplier coverage and tender outcomes.
4. Incorporate supply outage risk as a schedule fill-rate impact, not as a demand drop.

Because the prompt does not provide region, time horizon, or baseline scan volumes, no numeric forecast can be produced without fabricating inputs.

Is FDG F 18 protected by patents that influence market timing?

FDG F 18 is widely established and is used as a radiotracer product. Patent protection, where present, tends to be associated with manufacturing methods, formulations, radiochemical processes, or device-related aspects rather than the core imaging compound itself. A business-critical “market projection” linked to patent expirations requires a specific patent estate map (jurisdictions, claim scope, expiry dates, and enforcement status). No patent list or dataset is provided in the prompt, so a complete patent-linked projection cannot be generated accurately.

What is the correct way to interpret a “clinical trials update” for FDG F 18?

For established radiotracers like FDG F 18, trial activity often focuses on:

• Comparative diagnostic performance (protocols, quantification methods, thresholds).
• Indications expansion (new tumor types, clinical staging questions).
• Imaging biomarkers and response assessment frameworks.
• Operational endpoints such as reproducibility, image quality, and standardization.

An investment-grade update must be built from registry-tracked endpoints and trial phase status by sponsor and indication. No registry dataset is included in the prompt, so no definitive trial-state summary can be provided.

Key Takeaways

• FDG F 18 demand is structurally linked to PET utilization and scanner operations; projections should be supply-chain and schedule fill-rate driven, not discovery-driven.
• A complete “clinical trials update” and patent-linked projection cannot be produced from the information provided; registry and patent estate data are required to avoid fabrication.
• The highest-impact forecasting variables are reliable radiotracer supply capacity, lot release throughput, and regional distribution windows.

FAQs

1) What is FDG F 18 used for?

FDG F 18 is used as a PET imaging radiotracer to visualize metabolic activity in tissues, most commonly in oncology and other clinical pathways where metabolic imaging informs diagnosis and monitoring.

2) Why does supply reliability matter more for FDG F 18 than for many drugs?

Because FDG F 18 is time-sensitive for administration after production and has short radionuclide decay, scheduling and regional distribution constraints can directly affect whether centers can administer doses when needed.

3) What drives FDG F 18 demand?

PET scan volumes and PET center utilization rates across indications drive dose demand. Utilization growth and expansion of PET services are the primary volume drivers.

4) Can clinical trials change FDG F 18 market size significantly?

Clinical trials can shift utilization patterns through protocol adoption and indication refinement, but the core compound’s market is largely utilization- and supply-driven rather than phase-dependent like a novel therapeutics pipeline.

5) What data is most important for forecasting FDG F 18 revenues?

Regional administered-dose equivalents (scan counts), supply coverage and fill rate, procurement contracting dynamics, and logistics performance determine whether booked clinical demand converts to delivered administrations.

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References

[1] U.S. Food and Drug Administration (FDA). “Fludeoxyglucose F 18” (product and labeling information). FDA Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] European Medicines Agency (EMA). EPAR and related information for radiopharmaceutical products containing fludeoxyglucose (where applicable). https://www.ema.europa.eu/
[3] ClinicalTrials.gov. “Fludeoxyglucose F 18” search results and registry listings. https://clinicaltrials.gov/