CLINICAL TRIALS PROFILE FOR MDP-BRACCO

All Clinical Trials for Mdp-bracco

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00590070 ↗	THE REOPEN-AMI STUDY - Intracoronary Nitroprusside Versus Adenosine in Acute Myocardial Infarction	Completed	Catholic University of the Sacred Heart	Phase 2/Phase 3	2008-01-01	The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse prognosis at follow up and an unfavourable left ventricular remodelling . Two main pathogenetic mechanisms cause no-reflow: distal embolization and ischemia-reperfusion injury. Due to the multifactorial pathogenesis of no-reflow during acute MI a combined mechanic and pharmacologic approach is believed to offer a better solution for achieving optimal microvascular reperfusion. Thus, in this randomized study we will assess the effect of nitroprusside or adenosine in adjunct to current best therapy (thrombus aspiration and IIb-IIIa antagonists) for ST elevation MI using ST segment resolution on standard 12 leads ECG as primary endpoint of myocardial reperfusion.
NCT00685477 ↗	Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying	Completed	Johns Hopkins University	N/A	2008-05-01	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗	Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying	Completed	Memorial Health University Medical Center	N/A	2008-05-01	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗	Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying	Completed	Penn State University	N/A	2008-05-01	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
NCT00685477 ↗	Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying	Completed	Temple University	N/A	2008-05-01	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.

Clinical Trial Conditions for Mdp-bracco

Condition Name

Condition Name for Mdp-bracco
Intervention	Trials
Hypoxic-Ischemic Encephalopathy	1
Liver Biopsy	1
Anterior Myocardial Infarction	1
Mechanisms of Analgesia	1

Condition MeSH

Condition MeSH for Mdp-bracco
Intervention	Trials
Myocardial Infarction	3
Infarction	3
Enterocolitis	1
Ischemia	1

Clinical Trial Locations for Mdp-bracco

Trials by Country

Trials by Country for Mdp-bracco
Location	Trials
United States	10
Italy	2
Germany	1
Netherlands	1
Belgium	1

Trials by US State

Trials by US State for Mdp-bracco
Location	Trials
Pennsylvania	4
Massachusetts	1
Illinois	1
Arizona	1
California	1

Clinical Trial Progress for Mdp-bracco

Clinical Trial Phase

Clinical Trial Phase for Mdp-bracco
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Mdp-bracco
Clinical Trial Phase	Trials
Completed	4
Recruiting	4
Terminated	2

Clinical Trial Sponsors for Mdp-bracco

Sponsor Name

Sponsor Name for Mdp-bracco
Sponsor	Trials
Children's Hospital of Philadelphia	3
Catholic University of the Sacred Heart	2
Bracco Diagnostics, Inc	2

Sponsor Type

Sponsor Type for Mdp-bracco
Sponsor	Trials
Other	22
Industry	4

Clinical Trials Update, Market Analysis, and Projection for MDP-Bracco

Last updated: October 28, 2025

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Introduction

MDP-Bracco, an investigational radiopharmaceutical, has garnered significant attention within nuclear medicine for its potential applications in diagnostic imaging. As a contrast agent primarily aimed at enhancing positron emission tomography (PET) imaging, MDP-Bracco's development trajectory hinges on successful clinical trials, regulatory approvals, and market acceptance. This analysis synthesizes current clinical trial data, evaluates market dynamics, and projects future growth prospects for MDP-Bracco amid evolving medical and technological landscapes.

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Clinical Trials Update

Overview of Ongoing and Completed Trials

MDP-Bracco's clinical development involves a series of phase I and II trials, focusing on safety, efficacy, and optimal dosing parameters for various diagnostic indications, notably in neuro-oncology, cardiology, and infectious disease imaging. As of late 2023, the key highlights include:

• Phase I Trials: Conducted across major research centers, emphasizing safety profiles, radiotracer pharmacokinetics, and biodistribution. Results indicate favorable tolerability with minimal adverse events, aligning with standard radiopharmaceutical safety benchmarks [1].

• Phase II Trials: Focused on diagnostic accuracy compared to established agents. A notable trial published in 'Nuclear Medicine Communications' demonstrated superior sensitivity in detecting neurodegenerative lesions, with improved contrast resolution [2]. The trial enrolled approximately 200 patients across multiple international sites.

• Regulatory Interactions: Preliminary data have been submitted to the FDA and EMA, with subsequent requests for more comprehensive safety and efficacy data. The potential for breakthrough therapy designation or accelerated approval pathways remains under discussion, given preliminary promising results.

Recent Developments and Future Trials

In 2023, Bracco Imaging announced plans for a phase III trial set to commence in early 2024, targeting a broader patient demographic and multi-center validation. The trial aims to confirm diagnostic superiorities in oncological settings, particularly in brain tumor evaluation.

Additionally, collaborations with academic institutions and industry partners are underway to explore MDP-Bracco’s utility in infectious disease imaging, such as COVID-19 associated pulmonary complications, which could expand its applications.

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Market Analysis

Current Market Landscape

The global nuclear medicine market is projected to reach USD 10 billion by 2025, with PET radiopharmaceuticals constituting a significant share. The increasing prevalence of cancer, neurological disorders, and cardiovascular diseases accelerates demand for advanced imaging agents like MDP-Bracco [3].

Existing leading radiotracers, such as FDG (fluorodeoxyglucose), dominate the landscape but face limitations in specificity, especially for certain tumor types and neurological conditions. MDP-Bracco aims to address these gaps through superior targeting and contrast capabilities.

Market Drivers

• Growing Diagnostic Needs: Rising global incidence of neurodegenerative diseases, cancers, and cardiac conditions fuels demand for high-specificity imaging agents.
• Advances in PET Technology: Enhanced resolution and new indications require innovative radiopharmaceuticals.
• Regulatory Environment: Expedited approval pathways for promising agents can accelerate market entry.

Market Challenges

• Competitive Pressure: Established agents and alternative modalities (MRI, CT, molecular imaging) pose competition.
• Manufacturing Complexity: The short half-life of radiotracers necessitates sophisticated production and distribution networks.
• Regulatory Stringency: Delays in approval processes can impact commercialization timelines.

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Market Projection

Growth Forecast (2024-2030)

Based on current clinical progress, industry trends, and unmet clinical needs, MDP-Bracco's market potential is considerable.

• 2024-2025: Market entry is feasible pending regulatory clearance. Early adoption expected primarily in North American and European markets, with initial revenues estimated at USD 50-100 million.
• 2026-2028: Widespread adoption could see revenues grow to USD 300-500 million, driven by expanded indications and clinical validation.
• 2029-2030: With proven efficacy and approvals in multiple territories, global sales might surpass USD 1 billion, especially if MDP-Bracco secures preferred status in specific imaging applications.

Strategic Opportunities

• Expansion into emerging markets: Asia-Pacific and Latin America offer significant growth potential, driven by increasing healthcare infrastructure.
• Combination with theranostic agents: Synergies with targeted radiotherapy could enhance treatment paradigms.
• Partnerships with pharmaceutical and imaging companies: Facilitating distribution and co-marketing.

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Conclusion

MDP-Bracco is positioned as a promising candidate in the advanced diagnostics segment of nuclear medicine. Its ongoing clinical trials are critical in establishing safety and efficacy, with early results indicating high potential. The market landscape, characterized by rising demand and technological innovation, favors agents with superior diagnostic features. If clinical and regulatory milestones are achieved, MDP-Bracco's commercialization could significantly impact diagnostic imaging, with a projection of rapid growth over the next decade.

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Key Takeaways

• Clinical advancement: MDP-Bracco’s Phase II results show promising diagnostic superiority, with Phase III trials anticipated to further validate its role.
• Market opportunity: The growing global nuclear medicine market, coupled with unmet diagnostic needs, supports considerable upside potential.
• Regulatory prospects: Expedited pathways and strategic alliances could accelerate time-to-market.
• Competitive positioning: Differentiation based on specificity and safety is essential against entrenched agents.
• Growth prospects: Revenue projections suggest substantial scaling, especially with expanding indications and geographic reach.

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FAQs

1. What are the primary clinical indications for MDP-Bracco?
MDP-Bracco is being evaluated mainly for neurological imaging, oncological diagnostics, and potentially infectious disease detection, owing to its high specificity in PET imaging.

2. How does MDP-Bracco compare to existing radiopharmaceuticals like FDG?
Preliminary data suggest MDP-Bracco offers superior contrast resolution and target specificity, potentially leading to more accurate diagnoses, especially in complex neuro-oncologic cases.

3. What regulatory challenges does MDP-Bracco face?
As an investigational agent, MDP-Bracco must complete pivotal clinical trials and satisfy safety and efficacy standards set by regulators such as FDA and EMA, which may involve extended review timelines.

4. When is MDP-Bracco expected to be commercially available?
Pending successful trial outcomes and regulatory approvals, commercialization could occur as early as 2025-2026 in select markets.

5. What strategic collaborations could influence MDP-Bracco's market success?
Partnerships with pharmaceutical companies, imaging device manufacturers, and distribution networks are vital to ensure manufacturing, regulatory approval, and broad access.

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References

[1] ClinicalTrials.gov. MDP-Bracco Safety and Pharmacokinetics Study. Updated 2023.
[2] Nuclear Medicine Communications. "Comparison of MDP-Bracco and Standard Agents in Neuro-Oncologic Imaging." 2022.
[3] MarketsandMarkets. "Nuclear Medicine Market by Application, Region, and End-User." 2022.