Feasibility study to assess the incremental value of DeclipseSPECT during radioactive seed localisation in breast cancer surgery.

Feasibility study to assess the incremental value of DeclipseSPECT during radioactive seed localisation in breast cancer surgery. - Freehand-SPECT I-125 localisations for breast cancer surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40653

Enrollment

Registered

2014-11-06

Start date

2015-01-06

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Breast cancer Breast tumour

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Woman - Age > 18 - Histological proven breast cancer - I-125 seed at the right place in the tumour - Scheduled for breast tumour lumpectomy by RSL - Patients Provide writen *informed consent*

Exclusion criteria

Exclusion criteria: - A pre-treated breast tumour.

Design outcomes

Primary

Measure	Time frame
Primary Objective: The primary objective of the present study is to assess the feasibility of using the declipseSPECT system for accurate I-125 seed localisations in breast cancer surgery. • The outcome is a subjective opinion of the surgeon where it states that the declipseSPECT is useful or not for I-125 seed localisations and depth indications. This is scored by a 5-point scale.	—

Secondary

Measure	Time frame
Endpoint: Assess the accuracy of I-125 seed detection with freehand-SPECT compared to conventional gamma probe localisation. • The outcome will be a distance in mm for the mismatch between the conventional gamma probe measurement and the freehand-SPECT localisation on the skin. Endpoint: To determine if it is feasible to predict the accuracy of a tumour excision based on the location of the I-125 in the excision specimen. • The outcome will be a measure for eccentricity of the I-125 in the specimen. The closest margin will be written down.	—

Measure

Time frame

Endpoint: Assess the accuracy of I-125 seed detection with freehand-SPECT compared to conventional gamma probe localisation. • The outcome will be a distance in mm for the mismatch between the conventional gamma probe measurement and the freehand-SPECT localisation on the skin. Endpoint: To determine if it is feasible to predict the accuracy of a tumour excision based on the location of the I-125 in the excision specimen. • The outcome will be a measure for eccentricity of the I-125 in the specimen. The closest margin will be written down.

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Countries

Netherlands

Outcome results