# Treatments Against RA and Effect on FDG PET CT:The TARGET Trial

> **NIH NIH U01** · BRIGHAM AND WOMEN'S HOSPITAL · 2020 · $180,878

## Abstract

Project Summary/Abstract
There is a lack of information available on researchers’ attitudes and beliefs regarding incidental research
findings and the prevalence of incidental research findings from state of the art imaging studies, such as
whole body FDG PET/CT in those without known malignancy, and to our knowledge, no such information
available in rheumatology. The Treatments Against RA (Rheumatoid Arthritis) and Effect on FDG PET/CT
(TARGET) study provides an unprecedented and unique opportunity to examine the ethics around
incidental findings from whole body FDG PET/CT in RA patients without known malignancy. With the
evolving technological advancements in healthcare, we will inevitably discover more incidental findings in
research. There is consensus that incidental findings of potential clinical significance must be returned to
research participants. However, returning incidental findings to participants leaves many unanswered
questions for researchers, such as how to explain the risks and benefits of discovering incidental findings
in the informed consent process and how to organize follow up for incidental findings. There are a number
of publications on participant views on incidental findings in imaging research and researcher views on
incidental findings in neuroimaging and genetic testing. However, there is a lack of information available
on researchers’ attitudes and beliefs regarding incidental research findings from state of the art imaging
studies such as whole body PET/CT. Additionally, data regarding the frequency of incidental imaging
findings in clinical trials is limited, and even more limited in rheumatology clinical trials. Determining the
prevalence of incidental research findings on whole body FDG PET/CT in RA and detection rate of
previously unknown malignancies has implications for policy, and to our knowledge, has not been
described in a RA population. Most of the data on incidental research findings from whole body FDG
PET/CT are in patients with known malignancy rather than in patients without known malignancy. While it
is recommended that researchers report incidental findings from research, more specific or standardized
guidance for outcome reporting of incidental findings or how researchers should manage incidental
findings is lacking. Currently, management of incidental imaging findings are left up to individual sites and
investigators, and are based on existing legal and ethical guidelines which are vague and unclear. There
is considerable variability in the management of incidental imaging findings between research sites, and
no clear consensus among researchers on how to handle incidental findings in imaging research.
Therefore, it is important that we 1. Determine researchers’ attitudes and beliefs regarding their
ethical obligation to return and manage incidental research findings from whole body FDG PET/CT
imaging studies and 2. Determine the prevalence of incidental research findings on whole body
FDG PET/...

## Key facts

- **NIH application ID:** 10128696
- **Project number:** 3U01AR068043-04S1
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Joan Marie Bathon
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $180,878
- **Award type:** 3
- **Project period:** 2020-09-10 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10128696

## Citation

> US National Institutes of Health, RePORTER application 10128696, Treatments Against RA and Effect on FDG PET CT:The TARGET Trial (3U01AR068043-04S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10128696. Licensed CC0.

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