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"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"


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

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

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