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Low-dose Imaging Technique (LITE)

NCT04350957 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-04-26

No results posted yet for this study

Summary

The purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast.

Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. Both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. To evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different MRI pictures of their breasts. The scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.

Conditions

Interventions

DIAGNOSTIC_TEST

Low-dose Imaging

We are comparing MRI image quality for diagnostic purposes. We hope to learn whether using a lesser dose (25%) of the FDA approved contrast agent, Gadavist®, is just as effective as a standard or full dose (100%) of the same contrast in a breast MRI. This research is being done because breast MRI's have repeatedly been shown to represent the most reliable imaging method for breast cancer screening and diagnosis, regardless of personal risk for breast cancer and radiographic breast density. However, there are growing concerns about getting frequent breast MRI examinations due to the deposition of gadolinium, a metal ion that is found in all breast MRI contrast agents. The FDA states that this deposition and retention is not known to have any long term side effects on patient. However, the researchers at the University of Chicago Medicine would like to further investigate this using a lesser dose of contrast agent than the recommended dose for breast MRI examinations.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Deepa Sheth, MD · University of Chicago

  • Gregory S Karczmar, PhD · University of Chicago

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2020-08-24
Completion
2020-08-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350957 on ClinicalTrials.gov