patients with first local recurrence of breast cancer MedDRA version: 12.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Product Name: 99m Tc albumin nanocolloid
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: 99m Tc albumin nanocolloid
Concentration unit: MBq megabecquerel(s)
Concentration t
Sponsors
AZIENDA USL DI FORLI`
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: clinical diagnosis and / or instrumental first episode of local recurrence of breast cancer parietal (B5, C4, C5, surgical biopsy), surgically removed with negative axillary objectivity and, in cases of doubt or with lymph nodes> 2cm, with ultrasound examination and possible agoaspirato negative; staging tests negative (rx thorax and / or tac chest, eco liver and / or tac abdomen, bone scintigraphy) performed over the last 6 months; previously undergone a mastectomy (at least 1 year) for breast carcinoma in situ or invasive histologically confirmed and resection margins free of neoplasia; previously undergone a biopsy of the LS were negative for the primary tumor is permissible, and should be reported in the data collection, the presence of isolated tumor cells (diameter =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: axillary lymph nodes clinically and instrumentally or cyto-histologically positive; presence of distant metastases from breast cancer; concomitant or previous malignancies other than the subject of the Study, except for cancers for which the patient is disease-free for at least 5 years; concomitant or previous malignancy in the contralateral breast; non-epithelial breast malignancies (sarcoma, lymphoma etc). psychiatric illness or other nature which preclude provide informed consent to treatment; are pregnant resolved; breastfeeding; known contraindications to the technique of LS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the feasibility of lymphoscintigraphy in identifying the LS in patients with parietal recurrence of breast cancer surgically removed previously undergone mastectomy and sentinel node biopsy negative. - To assess the predictive value negative (VPN) of the LS for the histology of the cord ipsilateral axillary;Secondary Objective: Assessing the accuracy of the LS of total cases and in the subgroup of patients treated radio.;Primary end point(s): Assess the feasibility of lymphoscintigraphy in identifying the LS in patients with parietal recurrence of breast cancer surgically removed previously undergone mastectomy and sentinel node biopsy negative. - To assess the predictive value negative (VPN) of the LS for the histology of the cord ipsilateral axillary | — |
Countries
Italy
Outcome results
None listed