Using optical spectroscopy for the detection of positive resection margins for invasive ductal carcinoma and ductal carcinoma in situ during breast conserving surgery

Using optical spectroscopy for the detection of positive resection margins for invasive ductal carcinoma and ductal carcinoma in situ during breast conserving surgery - Optical spectroscopy for margin assessment during breast conserving surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48369

Enrollment

193

Registered

2019-08-01

Start date

2019-07-01

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Breast cancer ductal carcinoma in situ invasive carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women undergoing breast conserving surgery, with or without previous treatment with neo-adjuvant chemotherapy

Exclusion criteria

Exclusion criteria: Suspected oversensitivity to light; e.g. patient who has had photodynamic therapy

Design outcomes

Primary

Measure	Time frame
In this non-randomized controlled trial study we want to investigate the accuracy of optical spectroscopy for the intra-operative detection of positive resection margins during breast conserving surgery. The main endpoint of this research will be the sensitivity and specificity of DRS for the detection of measurement locations that are positive for IDC or DCIS according to histopathologic evaluation.	—

Measure

Time frame

In this non-randomized controlled trial study we want to investigate the accuracy of optical spectroscopy for the intra-operative detection of positive resection margins during breast conserving surgery. The main endpoint of this research will be the sensitivity and specificity of DRS for the detection of measurement locations that are positive for IDC or DCIS according to histopathologic evaluation.

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Secondary

Measure	Time frame
We furthermore want to assess the usability of optical spectroscopy for intra-operative guidance. For this secondary study parameter we intend to use the System Usability Scale (SUS-score).	—

Countries

Netherlands

Outcome results