Trial Information
"The Efficacy of 'Radioguided Occult Lesion Localization' (ROLL) Versus 'Wire-guided Localization' (WGL) in Breast Conserving Surgery for Non-palpable Breast Cancer: a Randomized Clinical Trial"
Inclusion Criteria:
- Women ≥ 18 years, with a non-palpable breast carcinoma (cT1) that need to be treated
with a lumpectomy and sentinel node biopsy
Exclusion Criteria:
- Pregnant patients or patients who breast feed
- Patients with multi focal tumour growth
- Patients with only ductal carcinoma in situ or lobular carcinoma in situ in the core
biopsy
- Patients requiring breast amputation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Radicality, oncologic outcome
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
R van Hillegersberg, dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
UMCU
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
07/089
NCT ID:
NCT00539474
Start Date:
January 2008
Completion Date:
November 2011
Related Keywords:
- Breast Cancer
- ROLL trial
- Minimally invasive surgery
- Non palpable breast cancer
- Breast Neoplasms