NIH-funded research U01 cooperative agreement

Improving quality control in PET drug manufacturing.

Official title: Broad Implementation of a universal solution for quality control modernization in PET radio-pharmaceutical manufacturing industry.

Funded at Trace-Ability, INC. · NIH-10675471 · Data updated 2026-11-12

This study is working to make it easier and faster to produce important PET drugs used in medical imaging, so that patients can get the tests they need without delays.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionTrace-Ability, INC.
NIH-funded
Lab location1 site (Van Nuys, United States)
Project startSeptember 1, 2020
Project endAugust 31, 2025
Funding year2023
Award (this year)$1,000,000
NIH project number5U01FD006957-04
Project IDNIH-10675471 on NIH RePORTER

Who could benefit from this research

Could help

Patients requiring diagnostic imaging that utilizes PET drugs would be ideal candidates to benefit from this research.

Less likely to help

Patients who do not require PET imaging or those whose conditions are not addressed by PET drugs may not benefit from this research.

What this research studies

This project aims to enhance the production of PET drugs, which are crucial for diagnostic imaging in various medical conditions. By modernizing the quality control processes, the research seeks to overcome current challenges in throughput and regulatory compliance faced by PET drug manufacturers. The approach involves expanding a previously successful solution, Tracer-QC, to accommodate a wider range of PET drugs, thereby streamlining the manufacturing process and ensuring consistent quality. This could lead to more efficient production and availability of essential imaging products for patients.

Why it matters

Potential benefit: If successful, this research could lead to improved access to a wider variety of high-quality PET imaging products for patients.

How similar studies have gone: Previous research has shown success with the Tracer-QC solution for a specific PET tracer, indicating potential for broader application in the industry.

Where this research is happening

  • Trace-Ability, INC.
    Van Nuys, United States
    Active

Researchers

  • Principal investigator: Elizarov, Arkadij — Trace-Ability, INC.
  • Study coordinator: Elizarov, Arkadij

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.