# Enabling nationwide AD PET imaging to support most efficient clinical trials by adoption of radically simplified and standardized quality control in commercial production of AD PET tracers.

> **NIH NIH R44** · TRACE-ABILITY, INC. · 2021 · $1,256,349

## Abstract

Positron Emission Tomography (PET) is the most powerful imaging procedure relied upon in the management of
Alzheimer’s Disease (AD). It provides information on the molecular processes in the brain. PET imaging studies require
short-lived radioactive contrast agents called PET tracers. Multiple PET tracers have a strong predictive value in AD.
 The long-term objective of the proposed work is availability of AD PET imaging to broad AD population, which
enables (1) detection of disease in pre-symptomatic stage and (2) most effective clinical trials for development of AD
therapies. Both of these impacts lead to improved outcomes for AD patients. Thereby, this project is considered highly
relevant to the mission of National Institute on Aging (NIA).
 Trace-Ability plans to enable nationwide availability of AD PET imaging by eliminating production complexity rooted
in release testing of AD PET imaging tracers. The enabling solution will be demonstrated with of [F-18]Flortaucipir
(leading tau PET tracer with pending NDA) and [F-18]Florbetaben (FDA-approved Beta Amyloid PET tracer), thereby
demonstrating solution’s universal applicability to multiple AD PET products.
 Proposed solution relies on complete automation of release testing on Tracer-QC platform that has been validated
earlier with the most common PET tracer, F 18 Fludeoxyglucose (FDG) and demonstrated with [F-18]Florbetaben.
 Current experience has identified critical gaps that need to be filled in order to achieve broad commercial adoption of
these products. By filling these gaps with R&D focused on 2 specific aims, proposed Direct to Phase II project enables
rapid expansion of AD PET imaging to the broad AD population.
 Specific Aim 1: Achieve overall solution reliability required for broad commercial deployment by demonstrating
failure of <0.1% at Trace-Ability and <1% in the field. This aim will first require thorough assessment of the currently
known issues and potential risk factors. Next, we will define unique innovative technical solutions to each of the identified
risks and issues. Then, implementation of each solution will be followed by a solid proof of its effectiveness. Once all
solutions have been implemented, we will test the overall resulting reliability of the system in-house. After proving it to
ourselves by demonstrating <0.01% failure rate, we will deploy systems in the field to prove the desired reliability of >99%
in a variety of commercial AD PET tracer production environments.
 Specific Aim 2: Automated QC of AD PET tracers qualified at 4 commercial production facilities with a 30-day
regulatory mechanism for adding new sites. The regulatory challenge for adoption of automated QC solution at new sites
with new AD PET tracers is two-fold: (1) It requires thorough validation at each new site. (2) There is a 10-month FDA
approval process for each new manufacturer. Phase II R&D will yield effective and innovative Performance Qualification
(PQ) procedures that deliver solid ...

## Key facts

- **NIH application ID:** 10156578
- **Project number:** 1R44AG071409-01
- **Recipient organization:** TRACE-ABILITY, INC.
- **Principal Investigator:** Arkadij Elizarov
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,256,349
- **Award type:** 1
- **Project period:** 2021-02-01 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10156578

## Citation

> US National Institutes of Health, RePORTER application 10156578, Enabling nationwide AD PET imaging to support most efficient clinical trials by adoption of radically simplified and standardized quality control in commercial production of AD PET tracers. (1R44AG071409-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10156578. Licensed CC0.

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