Last reviewed · How we verify
NCT05113927: RCT
Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.
NA trial testing Selene in Breast Cancer in 482 participants. Completed in 21 October 2024.
23 September 2024
Quick facts
| Lead sponsor | Perimeter Medical Imaging |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 482 |
| Start date | 1 December 2021 |
| Primary completion | 23 September 2024 |
| Estimated completion | 21 October 2024 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Selene
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Perimeter Medical Imaging
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05113927
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
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- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other Perimeter Medical Imaging trials
Trials by the same sponsor.
- NCT04242277 — Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue. · completed
- NCT04314700 — Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in B · NA · terminated
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 NCT05113927 (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 Perimeter Medical Imaging
- Last refreshed: 2 December 2024
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/NCT05113927.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing