Last reviewed · How we verify
NCT07185568: MANOLA
IntraOperative UltraSound Guided vs Wire Guided vs Magnetic Seed Guided Breast-Conserving Surgery for Non-palpable Tumors
NA trial testing IOUS HydroMark™ in Breast Cancer in 1,302 participants. Not yet recruiting.
30 September 2027
Quick facts
| Lead sponsor | Istituto Oncologico Veneto IRCCS |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,302 |
| Start date | 4 May 2026 |
| Primary completion | 30 September 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 5 locations across Italy |
Drugs / interventions tested
- IOUS HydroMark™
- Magnetic Sirius Pintuition Seed®
- Wire localization (WL)
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Breast-Conserving Surgery — all drugs for Breast-Conserving Surgery →
Sponsor
Istituto Oncologico Veneto IRCCS — full company profile →
Who can join
18 and older, female only, with Breast Cancer or Breast-Conserving Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, randomized, open-label clinical trial that will enroll 1302 adult patients with non-palpable breast lesions. Participant eligible for the study will be randomized in a 1:1:1 ratio to one of the pre-surgery lesion localization: IOUS HydroMark™ (experimental arm A), magnetic Sirius Pintuition Seed® (experimental arm B) and the wire localization technique (control arm). The randomization will be stratified by lesion type (solid non-palpable (type B); non-solid non-palpable (e.g., microcalcification clusters, architectural distortive areas) (type C); post-NACT residual lesions (type D), and clinical center.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07185568
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Istituto Oncologico Veneto IRCCS 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 NCT07185568 (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 Istituto Oncologico Veneto IRCCS
- Last refreshed: 24 March 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/NCT07185568.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing