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NCT04478669: DBT
Digital Breast Tomosynthesis (DBT) to Improve Assessment of Resection Margins in Invasive Breast Cancer
trial in Invasive Breast Cancer in 250 participants. Completed in 15 February 2022.
15 February 2022
Quick facts
| Lead sponsor | Aarhus University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 17 September 2020 |
| Primary completion | 15 February 2022 |
| Estimated completion | 15 February 2022 |
| Sites | 1 location across Denmark |
Conditions studied
- Invasive Breast Cancer — all drugs for Invasive Breast Cancer →
- Mastectomy, Segmental — all drugs for Mastectomy, Segmental →
- Margins of Excision — all drugs for Margins of Excision →
Sponsor
Aarhus University Hospital
Who can join
19 and older, female only, with Invasive Breast Cancer or Mastectomy, Segmental. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The challenge of breast conserving surgery (BCS) is to obtain free resection margins, by removing the invasive tumor and the precursor cells: DCIS (Ductal Carcinoma in Situ). Consequently, 17%-25% of primary invasive breast cancer patients will need a repeat surgery. Repeat breast surgery has been associated with higher surgical risks, poorer cosmetic outcome and increased psychological and economic burden. Finding a precise method to obtain tumor- and DCIS-free resection margins during BCS is therefore strongly needed. The purpose with this study is to investigate if the need for a re-operation can be reduced by performing Digital Breast Tomosynthesis (DBT) of the resected tumor margins compared to the currently used standard X-ray during BCS.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Digital breast tomosynthesis versus X-ray of the breast specimen for intraoperative margin assessment: A randomized trial.
Palimaru Manhoobi I, Tramm T, Redsted S, Bodilsen A, et al · · 2024 · cited 4× · PMID 38064928 · DOI 10.1016/j.breast.2023.103616
Verify or expand the search:
- PubMed search for NCT04478669
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Aarhus University Hospital trials
Trials by the same sponsor.
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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 NCT04478669 (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 Aarhus University Hospital
- Last refreshed: 17 February 2022
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/NCT04478669.
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