The efficacy of radioguided occult lesion localisation (ROLL) versus wire guided lesion localisation (WGL) in breast conserving surgery for non palpable breast cancer: a randomised controlled trial

The efficacy of radioguided occult lesion localisation (ROLL) versus wire guided lesion localisation (WGL) in breast conserving surgery for non palpable breast cancer: a randomised controlled trial - ROLL trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35161

Enrollment

316

Registered

2007-07-31

Start date

2007-11-30

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

breast cancer breast carcinoma

Interventions

Wire Guided Localisation technique Patients in the WGL group will undergo intratumoural injection of a nuclear radiotracer under stereotactic or ultrasound guidance, after injection a scintigraphic

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a non palpable breast carcinoma who are eligible for a lumpectomy and sentinel node biopsy

Exclusion criteria

Exclusion criteria: - Pregnant or lactating patients - Patients with a multi focal carcinoma - Patients with ductal carcinoma in situ (DCIS) or a lobular carcinoma in situ (LCIS) without invasive growth

Design outcomes

Primary

Measure	Time frame
1) The percentage of tumour-free margins (invasive and in situ) after the ROLL vs. the WGL procedure (i.e. oncologic outcome). 2) The volume and maximum diameter of the lumpectomy of ROLL vs. WGL (i.e. cosmetic outcome).	—

Secondary

Measure	Time frame
1) The cost-effectiveness of ROLL vs. WGL (i.e. operation time, radiological localisation time, hospital stay and materials). 2) The degree of difficulty of the radiological and surgical procedure. 3) The degree of patient (dis)comfort of the radiological procedure ROLL vs. WGL (number of procedures, pain, complications). 4) The success rate of the sentinel node procedure (visualisation and localisation).	—

Measure

Time frame

1) The cost-effectiveness of ROLL vs. WGL (i.e. operation time, radiological localisation time, hospital stay and materials). 2) The degree of difficulty of the radiological and surgical procedure. 3) The degree of patient (dis)comfort of the radiological procedure ROLL vs. WGL (number of procedures, pain, complications). 4) The success rate of the sentinel node procedure (visualisation and localisation).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)