CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 1,528 target
Drug / intervention
SLNB is sparedprocedure
Likely dose
Not stated in record
Key inclusion· 10
  • Female gender
  • Age ≥18 years
  • Stage 1: Invasive ductal carcinoma or DCIS proven by core needle biopsy
  • Stage 2: Invasive carcinoma proven by core needle biopsy
Key exclusion· 9
  • Distant metastases
  • Currently undergoing neoadjuvant therapy
  • Positive preoperative axillary assessment (Stage 1)
  • Positive preoperative axillary assessment (Stage 2: PET mSUV≥0.27)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04072653
NCT04072653N/ARecruitingOn TrackUpdated 71mo ago
Long Recruiting

Sentinel Node Biopsy Vs Observation After Axillary PET Examination

Fudan University·interventional·Posted Aug 28, 2019·Updated Jul 13, 2020

In Brief

A clinical study evaluating SLNB is spared for Breast Cancer. Currently recruiting, targeting 1,528 participants across 1 site.

Detailed Summary

Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before operation. Therefore this prospective study are designed to evaluate the negative predictive value of LymphPET and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--

Timeline

N/ARecruiting
20202021202220232024202520262027
First PostedAug 28, 2019
Enrollment StartSep 4, 2019
Primary CompletionSep 1, 2027
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 6.8 years agoPrimary completion in 1.2 years

Interventions

SLNB is sparedprocedure

SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)