An Early Phase 1 interventional study of Implanted Medical Device and Therapeutic Conventional Surgery in Positive Axillary Lymph Node, Stage 0 Breast Cancer AJCC v6 and v7 and Stage I Breast Cancer AJCC v7, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by Jonsson Comprehensive Cancer Center · Early Phase 1, Interventional, and Treatment
This pilot clinical trial will evaluate whether the SCOUT reflector can be used to tag abnormal lymph nodes in patients with breast cancer prior to chemotherapy for targeted removal at the time of surgery. The SCOUT localization system with the SAVI reflector is non-radioactive and completely internal so can be placed into an abnormal lymph node prior to chemotherapy treatment, which theoretically will allow easier identification and therefore more reliable targeting of the abnormal lymph node for surgical removal.
PRIMARY OBJECTIVES:
I. Percentage of patients with successful retrieval of the reflector confirmed by specimen radiography.
II. Percentage of patients with successful retrieval of the biopsied node, confirmed by presence of clip, biopsy changes or treatment-related changes on pathology.
SECONDARY OBJECTIVES:
I. Total number of lymph nodes removed. II. Percentage of patients in which clipped node was a sentinel node. III. Percentage of patients with nodal pathologic complete response (PCR). IV. Residual cancer burden (RCB) score for patients with residual nodal disease.
V. Percentage of patients requiring axillary dissection. VI. Days prior to surgery of reflector insertion.
OUTLINE:
Patients undergo image-guided placement of the SCOUT reflector prior to course 2 of standard of care neoadjuvant chemotherapy. Patients undergo standard of care surgery approximately 4-8 weeks after chemotherapy completion.
Exclusion Criteria:
Patients undergo image-guided placement of the SCOUT reflector prior to course 2 of standard of care neoadjuvant chemotherapy. Patients undergo standard of care surgery approximately 4-8 weeks after chemotherapy completion.
Device: Implanted Medical Device · Procedure: Therapeutic Conventional Surgery
Undergo SCOUT reflector placement
Also known as: IMPLANTED
Undergo surgery
Percentage of patients with successful retrieval of reflector confirmed by specimen radiography
Time frame: Up to 2 years
Percentage of patients with successful retrieval of the biopsied node, confirmed by presence of clip, biopsy changes or treatment-related changes on pathology
Time frame: Up to 2 years
Total number of lymph nodes removed
Time frame: Up to 2 years
Percentage of patients in which clipped node was a sentinel node
Time frame: Up to 2 years
Percentage of patients with nodal pathologic complete response (PCR)
Time frame: Up to 2 years
Residual cancer burden (RCB) score for patients with residual nodal disease
Time frame: Up to 2 years
Percentage of patients requiring axillary dissection
Time frame: Up to 2 years
Days prior to surgery of tag insertion
Time frame: Up to 2 years
Incidence of adverse events
All adverse events due to these procedures will be recorded and reported to the institutional review board (IRB).
Time frame: Up to 2 years
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center