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NCT06636539
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
NA trial testing CEM Software in New Mammography Device in Breast Screening in 75 participants. Currently enrolling.
31 March 2026
Quick facts
| Lead sponsor | Hologic, Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 75 |
| Start date | 14 October 2024 |
| Primary completion | 31 March 2026 |
| Estimated completion | 31 March 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- CEM Software in New Mammography Device
Conditions studied
- Breast Screening — all drugs for Breast Screening →
Sponsor
Hologic, Inc.
Who can join
35 and older, female only, with Breast Screening. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06636539
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Screening
Currently open trials in the same condition.
- NCT03672331 — My Personalized Breast Screening · NA · active not recruiting
- NCT03233191 — Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer · Phase 3 · active not recruiting
Other Hologic, Inc. trials
Trials by the same sponsor.
- NCT05199701 — Prospective Case Collection Study for New Mammography Technologies · NA · recruiting
- NCT04671329 — A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy · NA · completed
- NCT03497234 — Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test · NA · withdrawn
- NCT03456583 — Brevera™ Breast Biopsy System Data Collection Study · completed
- NCT03300206 — A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System · completed
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 NCT06636539 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hologic, Inc.
- Last refreshed: 22 October 2025
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/NCT06636539.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing