ROLLIS: Radioguided Occult Lesion Localisation using Iodine Seeds to localise impalpable breast lesions: The Pilot Extension Study

Not Applicable

Completed

• Conditions: Breast cancer; Cancer - Breast; Surgery - Surgical techniques

• Registration Number: ACTRN12612000221853
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. Women aged over 40 years
2. Non-palpable breast tumour
4. Participant eligible for breast conserving surgery (BCS)
based on clinical and radiologic evaluation
6. Benign impalpable lesions, where participant requests
lesion be removed
7. Intraductal lesions (papillomas)
8. Lesions that are histologically indeterminate” on core
biopsy ( histology shows concerning features and removal
of further tissue for assessment to exclude cancer)
9. Insertion of up to two seeds per participant (either
to bracket” larger or elongated lesions or for multiple
lesions (two in one breast or one in each breast)
10.Periareolar lesions (providing the participant does not
require scintigraphy for sentinel node biopsy)

Exclusion Criteria

1. Male patient
2. Female, age less than 40 years
3. Pregnancy or lactation
4. Periareolar lesion (where sentinel lymph node localization is
required)
5. Contraindication to breast conserving surgery
6. Recent Nuclear Medicine or PET radioisotope administration that may adversely affect the procedure (isotopes with long half life eg gallium 67, thallium )

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All lesions and seeds successfully removed from the participants with return of the seed to Medical Physics for disposal[Removal of lesion assessed at time of pathology review of specimen the next working day after surgery, pathologist describes lesion as being present and for malignant lesions, whether any margins are <10mm.<br>Removal of Seed assessed at time of surgery by finding high count levels within specimen using gamma probe, and visualisation of seed within specimen on specimen radiograph Physicist documents collection of all seeds on the day the specimen is sectioned by the pathologist. This is usually the next working day following the day of surgery.]

Secondary Outcome Measures

Name	Time	Method
Participants are asked to complete two questionnaires: the first at the time of the surgical follow-up appointment is to assess their experience with the procedure<br>The second is posted to them 6 months later and is to assess how they feel about the cosmetic result of their surgery[One week post op<br>Six months post op];A wide range of Multidisciplinary Breast Group Team members gain proctored experience and develop expertise in using the technique[Radiologist, surgeon (on day of surgery) and pathologist (on day of seed removal) complete questionnaires relating to ease of performing the procedure and the degree to which they depended on the wire or the seed to locate an remove the lesion.]