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Three-dimensional bREast ultraSound for resPOnse evaluation of Neo-aDjuvant chEmotheRapy; an adequate replacement for MRI in breast cancer patients? (RESPONDER trial)

Three-dimensional bREast ultraSound for resPOnse evaluation of Neo-aDjuvant chEmotheRapy; an adequate replacement for MRI in breast cancer patients? (RESPONDER trial)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20208
Enrollment
96
Registered
2017-11-08
Start date
2017-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, neoadjuvant chemotherapy, tumour response evaluation

Interventions

Performing a three-dimensional ultrasonography in addition to the breast MRI (standard of care) to evaluate the tumour response during neoadjuvant chemotherapy in breast cancer patients. The three-di

Sponsors

Erasmus Medical Centre, Cancer Institute Erasmus Medical Centre, Department of Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Female Aged > 18 year Adenocarcinoma of the breast visible on ultrasonography

Exclusion criteria

Exclusion criteria: T4 breast cancer stadium (i.e. tumor of any size growing in to the chest wall or skin)

Design outcomes

Primary

MeasureTime frame
Concordance between longest tumour diameter during response evaluation. Longest diameter will be accessed and compared between the (conventional) MRI and the ABVS.

Secondary

MeasureTime frame
1) The concordance of volume (instead of longest diameter) response evaluation of the (conventional) MRI and the ABVS; 2) The diagnostic accuracy of the ABVS to predict a pathologic complete response; 3) Patients preferences as measured by a questionnaire; 4) The costs of the response evaluation by the (conventional) MRI as compared to the ABVS.

Contacts

Public ContactL.B. Koppert,

Department of Surgery, Erasmus MC Cancer Institute PO Box 5201

l.koppert@erasmusmc.nl(010-70)41161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)