Low-dose Imaging Technique (LITE)

NCT04350957 | Withdrawn DMC

• 1 other identifier: IRB20-0528
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Low-dose Lesion Enhancement

  Readers will initially be provided with two MIP images and asked to decide on presence or absence of significant enhancement. The two MIP images will be created from the low dose images and the standard dose images respectively.

  Through study completion, an average of 1 year

Study Arms (1)

Low-dose Imaging

EXPERIMENTAL

Enrolled patients will undergo two separate dynamic contrast-enhanced MRI's, one with 25% of the contrast dose and one with 100% of the contrast dose recommended by weight. During the first visit, the subject will receive 25% of the standard dose of contrast media 0.1 mM/kg will be administered at 2 mls/second followed by the acquisition of a series of DCE images. On the second visit, the subject will receive 100% of the contrast media followed by the same imaging protocol as the one subsequent to the first contrast administration.

Diagnostic Test: Low-dose Imaging

Interventions

Low-dose Imaging DIAGNOSTIC_TEST

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.

Low-dose Imaging

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between the ages of 18-80
• Women with a suspected or biopsy proven enhancing lesion

You may not qualify if:

• Women with a history of adverse reactions to contrast media
• Women with GFR below 30 mL/min/1.73m2
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• University of Chicago: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Deepa Sheth, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Gregory S Karczmar, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical trial has a single arm. All subjects will receive a low dose and standard dose on two separate days

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: August 24, 2020
• Primary Completion: August 24, 2020
• Study Completion: August 24, 2020
• Last Updated: April 26, 2023

Record last verified: 2023-04