Positive Axillary Lymph NodeEarly Phase 1NCT03411070
SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer
A Early Phase 1 study testing Implanted Medical Device and Therapeutic Conventional Surgery in people with Positive Axillary Lymph Node and Stage 0 Breast Cancer AJCC v6 and v7, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Positive Axillary Lymph Node, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7
- What is being tested?
- Implanted Medical Device and Therapeutic Conventional Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2019to 6 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Using Radar Technology to Tag Abnormal Lymph Nodes for Removal During Surgery Following Neoadjuvant Chemotherapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- 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
- Being tested
- Implanted Medical Device, Therapeutic Conventional Surgery
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implanted Medical DeviceDevice
Also called IMPLANTED
Undergo SCOUT reflector placement
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SCOUT reflector surgery) | Experimental | 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. Receives: Device: Implanted Medical Device; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with successful retrieval of reflector confirmed by specimen radiography
Measured: 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
Measured: Up to 2 years
Secondary outcomes (7)
Total number of lymph nodes removed
Measured: Up to 2 years
Percentage of patients in which clipped node was a sentinel node
Measured: Up to 2 years
Percentage of patients with nodal pathologic complete response (PCR)
Measured: Up to 2 years
Residual cancer burden (RCB) score for patients with residual nodal disease
Measured: Up to 2 years
Percentage of patients requiring axillary dissection
Measured: Up to 2 years
Days prior to surgery of tag insertion
Measured: 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).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start7 Apr 2019
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Positive Axillary Lymph NodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Faxitron bioptics, LLC
- Responsible party
- Sponsor
- Investigators
- Jennifer Baker, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411070
- Sponsor's protocol ID
- 17-001864
- Other IDs
- NCI-2017-02394
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2018
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Baker JL, Haji F, Kusske AM, Fischer CP, Hoyt AC, Thompson CK, Lee MK, Attai D, DiNome ML. SAVI SCOUT(R) localization of metastatic axillary lymph node prior to neoadjuvant chemotherapy for targeted axillary dissection: a pilot study. Breast Cancer Res Treat. 2022 Jan;191(1):107-114. doi: 10.1007/s10549-021-06416-z. Epub 2021 Oct 15.
PubMed 34652548
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Radar Technology to Tag Abnormal Lymph Nodes for Removal During Surgery Following Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03411070
- Acronym / sponsor ID
- 17-001864
- Conditions
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Faxitron bioptics, LLC
- Study start
- 7 Apr 2019 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SCOUT reflector surgery) | Experimental | Device: Implanted Medical Device, Procedure: Therapeutic Conventional SurgeryPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implanted Medical DeviceAlso: IMPLANTEDUndergo SCOUT reflector placement | Device | Treatment (SCOUT reflector surgery) |
| Therapeutic Conventional SurgeryUndergo surgery | Procedure or surgery | Treatment (SCOUT reflector surgery) |
Primary outcome
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
7 secondary outcomes
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
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 34652548Baker JL, Haji F, Kusske AM, Fischer CP, Hoyt AC, Thompson CK, Lee MK, Attai D, DiNome ML. SAVI SCOUT(R) localization of metastatic axillary lymph node prior to neoadjuvant chemotherapy for targeted axillary dissection: a pilot study. Breast Cancer Res Treat. 2022 Jan;191(1):107-114. doi: 10.1007/s10549-021-06416-z. Epub 2021 Oct 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Baker, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Implanted Medical Device and Therapeutic Conventional Surgery in people with Positive Axillary Lymph Node and Stage 0 Breast Cancer AJCC v6 and v7, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with successful retrieval of reflector confirmed by specimen radiography (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.