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SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03411070
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Positive Axillary Lymph Node Stage 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Device: Implanted Medical Device Procedure: Therapeutic Conventional Surgery Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Radar Technology to Tag Abnormal Lymph Nodes for Removal During Surgery Following Neoadjuvant Chemotherapy
Actual Study Start Date : April 7, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (SCOUT reflector surgery)
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
Undergo SCOUT reflector placement
Other Name: IMPLANTED

Procedure: Therapeutic Conventional Surgery
Undergo surgery




Primary Outcome Measures :
  1. Percentage of patients with successful retrieval of reflector confirmed by specimen radiography [ Time Frame: Up to 2 years ]
  2. 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 ]

Secondary Outcome Measures :
  1. Total number of lymph nodes removed [ Time Frame: Up to 2 years ]
  2. Percentage of patients in which clipped node was a sentinel node [ Time Frame: Up to 2 years ]
  3. Percentage of patients with nodal pathologic complete response (PCR) [ Time Frame: Up to 2 years ]
  4. Residual cancer burden (RCB) score for patients with residual nodal disease [ Time Frame: Up to 2 years ]
  5. Percentage of patients requiring axillary dissection [ Time Frame: Up to 2 years ]
  6. Days prior to surgery of tag insertion [ Time Frame: Up to 2 years ]
  7. Incidence of adverse events [ Time Frame: Up to 2 years ]
    All adverse events due to these procedures will be recorded and reported to the institutional review board (IRB).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to give written informed consent to participate in the study
  • Patients with a breast cancer diagnosis of any subtype and a biopsy-proven positive axillary lymph node who will be treated first with chemotherapy
  • Enlarged lymph node and/or clip targetable with image guidance
  • Patients who are eligible for surgical resection of the primary breast cancer and targeted dissection of the axilla

Exclusion Criteria:

  • More than 3 positive axillary nodes on imaging or matted nodes on clinical exam
  • Stage IV breast cancer
  • Pregnant or lactating females
  • Patients with inflammatory breast cancer
  • Patients with allergies to isosulfan blue or technetium, which would preclude sentinel node mapping
  • Patients who have had previous axillary surgery, including sentinel lymph node biopsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411070


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Maggie L. DiNome    424-259-8791    mdinome@mednet.ucla.edu   
Principal Investigator: Maggie L. DiNome         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Maggie DiNome UCLA / Jonsson Comprehensive Cancer Center

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03411070     History of Changes
Other Study ID Numbers: 17-001864
NCI-2017-02394 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
17-001864 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type