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Compares treatment options for Breast Cancer
Official title Sentinel Node Biopsy Vs Observation After Axillary PET
ClinicalTrials.gov ID: NCT04072653
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- stage 1:
- female
- ≥18 years old
- invasive ductal carcinoma or DCIS proved by core needle biopsy
- tumor size ≤ 5cm
You likely can't join if
- stage 1:
- distant metastases
- in the procedure of neoadjuvant therapy
- positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
- pregnancy or breastfeeding
- axillary biopsy or axillary surgery before LymphPET
See the full eligibility criteria
- stage 1:
- female
- ≥18 years old
- invasive ductal carcinoma or DCIS proved by core needle biopsy
- tumor size ≤ 5cm
- negative preoperative axillary assessment(including body examination, ultrasound and MR examination)
- patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection) stage 2:
- female
- ≥18 years old
- invasive carcinoma proved by core needle biopsy
- has plan for breast conserving surgery and adjuvant radiation after surgery
- negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV\<0.27)
- patients is accessible for the follow up
- stage 1:
- distant metastases
- in the procedure of neoadjuvant therapy
- positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
- pregnancy or breastfeeding
- axillary biopsy or axillary surgery before LymphPET
- suffer from diabetes mellitus and without well control of bloodglucose
- previous malignancy
- allergic to tracer of LymphPET stage 2:
- distant metastases
- in the procedure of neoadjuvant therapy
- positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27)
- pregnancy or breastfeeding
- axillary biopsy or axillary surgery before LymphPET
- suffer from diabetes mellitus and without well control of bloodglucose
- previous malignancy
- allergic to tracer of LymphPET
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.