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Artificial Intelligence

AI-Assisted Low-Dose Gadolinium Breast MRI for Breast Cancer

Phase 1
Waitlist Available
Led By Stefanie Woodard, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patient between ≥ 18 years old and ≤ 99 years old
Female patients between ≥ 18 years old and ≤ 99 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1st soc breast mri to 2nd low-dose breast mri (48 hours to 14 days later).
Awards & highlights

Study Summary

This trial will test if AI can help doctors better detect breast cancer using a low dose of gadolinium.

Who is the study for?
This trial is for women aged 18-99 who need a breast MRI, either because they're being screened or have known breast lesions. It's open to those with new primary breast cancer but not recurrent cases. Participants must be able to lie still for an hour and can't join if pregnant, breastfeeding, under 18, have had neoadjuvant chemotherapy, or can't undergo MRI.Check my eligibility
What is being tested?
The study compares two types of breast MRIs: one uses a quarter dose of gadolinium contrast with AI assistance; the other is the standard full-dose MRI without AI. The goal is to see if AI can help diagnose benign and malignant lesions accurately even with less contrast agent.See study design
What are the potential side effects?
Reducing the gadolinium dose may lower risks associated with its deposition in the brain. Side effects are not detailed but could include typical MRI-related discomforts such as claustrophobia or reactions to lower doses of contrast.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 to 99.
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I am a woman aged 18 to 99.
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I have been recently diagnosed with breast cancer for the first time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1st soc breast mri to 2nd low-dose breast mri (48 hours to 14 days later).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1st soc breast mri to 2nd low-dose breast mri (48 hours to 14 days later). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare lesion conspicuity on a scale of 1-4 from low-dose and SOC-dose imaging.
Compare lesion internal enhancement pattern on a scale from 1-4 from low-dose and SOC- dose imaging.
Compare lesion margins on a scale from 1-4 from low-dose and SOC-dose imaging.
+1 more
Secondary outcome measures
Compare the overall background enhancement (scale per standard imaging guidelines. Minimal, mild, moderate, marked).

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects with enhancing breast lesionsExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,024 Total Patients Enrolled
32 Trials studying Breast Cancer
4,491 Patients Enrolled for Breast Cancer
Bracco CorporateIndustry Sponsor
6 Previous Clinical Trials
559 Total Patients Enrolled
Stefanie Woodard, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
245 Total Patients Enrolled

Media Library

Reduced Dose Gadolinium Breast MRI with AI (Artificial Intelligence) Clinical Trial Eligibility Overview. Trial Name: NCT04340180 — Phase 1
Breast Cancer Research Study Groups: Subjects with enhancing breast lesions
Breast Cancer Clinical Trial 2023: Reduced Dose Gadolinium Breast MRI with AI Highlights & Side Effects. Trial Name: NCT04340180 — Phase 1
Reduced Dose Gadolinium Breast MRI with AI (Artificial Intelligence) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04340180 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being accepted into this scientific experiment?

"As evidenced on clinicaltrials.gov, this medical investigation is actively pursuing participants and was first posted in mid-July 2021, with the latest update being issued late December of the same year."

Answered by AI

How many participants are eligible for inclusion in this clinical trial?

"Affirmative. As per the information available on clinicaltrials.gov, this clinical trial is still open for recruitment of participants; it was first posted in July 2021 and its details have been edited most recently in December 2021. This experiment requires 20 patients to be recruited from one medical facility."

Answered by AI

What criteria must a person meet to qualify for this trial?

"To meet the criteria of this study, applicants must present a diagnosis of breast cancer and be aged between 18-99. Approximately 20 individuals will be selected for involvement in the trial."

Answered by AI

What earlier research has been done involving the use of gadolinium Breast MRI in conjunction with Standard of Care (SOC)?

"Presently, 10 ongoing studies are investigating the efficacy of Standard of Care (SOC) gadolinium Breast MRI with no trials in Phase 3. Major centers conducting this research include Portland, Oregon and a total of 26 sites across the country."

Answered by AI

Is the utilization of gadolinium Breast MRI for Standard of Care purposes endorsed by the FDA?

"Given the limited data available on Standard of Care (SOC) gadolinium Breast MRI, Power has provisionally rated its safety at a 1 out of 3."

Answered by AI

Does this trial have an age requirement, and if so, to what extent?

"The eligibility criteria for this clinical trial requires that potential participants are between 18 and 99 years of age. There are 362 trials specifically targeting minors, whereas 4279 research studies cater to elderly populations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
Stefanie A. Woodard 2021. "Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04340180.
~3 spots leftby Sep 2024
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