Last reviewed · How we verify
NCT04340180
Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
Phase 1 trial testing Standard of Care (SOC) gadolinium Breast MRI in Breast Benign Tumor in 20 participants. Completed in 20 January 2026.
29 September 2022
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 20 |
| Start date | 14 July 2021 |
| Primary completion | 29 September 2022 |
| Estimated completion | 20 January 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Standard of Care (SOC) gadolinium Breast MRI — full drug profile →
- reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation. — full drug profile →
Conditions studied
- Breast Benign Tumor — all drugs for Breast Benign Tumor →
- Breast Malignant Tumor — all drugs for Breast Malignant Tumor →
Sponsor
University of Alabama at Birmingham
Who can join
Adults 18 to 99, female only, with Breast Benign Tumor or Breast Malignant Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the ability of AI to correctly aid in characterization of benign and malignant lesions even when a low dose of gadolinium is administered. This study is relevant for several reasons, most notably being the reduction of MRI dose and decreased gadolinium deposition in the brain. In addition, use of AI may provide increased sensitivity and specificity for the radiologist evaluating a breast MRI exam. Half of the population will have benign pathologies and the other half will have malignant pathologies.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tribulations and future opportunities for artificial intelligence in precision medicine.
Carini C, Seyhan AA. · · 2024 · cited 67× · PMID 38702711 · DOI 10.1186/s12967-024-05067-0
Verify or expand the search:
- PubMed search for NCT04340180
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04340180 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
- Last refreshed: 22 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04340180.
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