SAVI Scout for Breast Lesions

Overseen By Tanya Moseley, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Distant metastasis, Inflammatory breast carcinoma, Nickel allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called SAVI Scout, which helps surgeons locate and remove breast tumors more precisely. The device, already approved for use, uses infrared light to guide the surgeon to the tumor. The trial seeks individuals with specific types of breast cancer, particularly those with a single tumor confirmed through imaging or biopsy. Participants should not have a nickel allergy or certain medical implants. This trial may suit those undergoing treatment for breast cancer who meet these criteria. As an Early Phase 1 trial, the research focuses on understanding how the SAVI Scout device functions in people, offering participants the chance to contribute to advancements in surgical precision for breast cancer treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have active cardiac implants, you cannot participate.

What prior data suggests that the SAVI Scout device is safe for breast lesion localization?

Research has shown that the SAVI Scout system, approved by the FDA since 2014, is safe. In 2017, the FDA approved it for long-term use without time limits, further confirming its safety.

Doctors use this system in surgeries like lumpectomies to remove breast cancer lumps. Studies indicate that it helps doctors locate and remove tumors more accurately, leading to better outcomes. Although specific safety statistics aren't mentioned, this information suggests patients generally tolerate it well.

In summary, the SAVI Scout system has been safely used in many procedures since its approval, indicating a strong safety record in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional methods for locating breast tumors, which often rely on wire localization techniques, the SAVI Scout® system is unique because it uses a radar-based localization method. This system allows for more precise placement of a marker within the breast tumor, which can improve surgical accuracy and potentially lead to better outcomes for patients. Researchers are excited about this approach because it offers a less invasive, more comfortable experience for patients and could reduce the time spent in surgery, enhancing overall treatment efficacy and patient satisfaction.

What evidence suggests that the SAVI Scout device is effective for breast lesions?

Research has shown that the SAVI Scout system, which participants in this trial will receive, effectively locates breast lumps. Studies have demonstrated a success rate of over 99% for both placing and retrieving the marker used in this system. One study found that the system helped surgeons completely remove breast lumps, including cancerous ones, without requiring additional surgery. The technology uses infrared light and radar signals to guide surgeons precisely to the lump, facilitating accurate removal. This evidence supports the idea that SAVI Scout can effectively assist in breast surgeries by improving accuracy and reducing the need for follow-up procedures. ^{1 6 7 8 9}

Who Is on the Research Team?

Tanya Moseley, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with a confirmed diagnosis of unifocal invasive breast cancer or highly suspicious breast lesions. It's suitable for those undergoing mid-chemotherapy imaging if they're receiving neoadjuvant therapy. People with distant metastasis, certain concurrent trial participations, active cardiac implants, inflammatory breast carcinoma, or nickel allergy cannot participate.

Inclusion Criteria

My breast cancer is in early stages and confirmed by a biopsy.

I am over 18 years old.

Unifocal BIRADS-5 or -6 lesions at the time of diagnostic imaging

Exclusion Criteria

My breast cancer is inflammatory.

Nickel allergy

Patients with active cardiac implants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placement and Imaging

Placement of the SAVI Scout marker in the breast tumor under mammographic or sonographic guidance

1 week

1 visit (in-person)

Surgical Retrieval

Surgical excision of the breast lesion and confirmation of SAVI Scout marker removal

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgical retrieval

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAVI Scout®

Trial Overview The SAVI Scout system is being tested to help locate and remove suspicious breast lesions without using radiation. It involves implanting a small reflector into the lesion area and then using a handheld device during surgery to find it by sound and visual cues.

How Is the Trial Designed?

Group I: SAVI Scout® Experimental Treatment 1 Intervention

marker is accurately placed in the breast tumor

SAVI Scout® is already approved in United States for the following indications:

Approved in United States as SAVI Scout for:

• Localization of suspicious breast lesions
• Guidance for lumpectomy or excisional biopsy procedures

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a survey of 1264 parents in Uganda and Vietnam, 25% reported adverse events following immunization (AEFIs) after HPV vaccination, with the most common being pain or swelling at the injection site (62.0%) and fever (29.1%).

Most parents did not seek medical help for AEFIs, indicating that these events were generally mild, as 63.9% took no action and 16.1% managed symptoms at home, suggesting a need for better communication about expected vaccine reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring adverse events following immunisation in developing countries: experience from human papillomavirus vaccination demonstration projects. Jain, KM., Paul, P., LaMontagne, DS.[2013]

Dermatologists face challenges in assessing drug safety due to the vast number of skin conditions (over 3000 diagnoses), necessitating the use of diverse data sources including clinical trials and real-world evidence.

New therapies like dupilumab for atopic dermatitis and Janus-kinase inhibitors for alopecia areata are supported by evolving high-level evidence, highlighting the importance of both trial data and ongoing safety monitoring in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting. Asfour, L., Yiu, ZZN., Warren, RB.[2021]

In a study of 12,776 women aged 67-94 with ductal carcinoma in situ (DCIS) who underwent breast-conserving surgery, sentinel lymph node biopsy (SLNB) did not show any significant improvement in long-term outcomes such as treated recurrence, ipsilateral invasive occurrence, or breast cancer mortality compared to those who did not undergo SLNB.

The results suggest that routine SLNB may not be necessary for older patients with DCIS, as it did not provide additional benefits in terms of cancer recurrence or survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Sentinel Lymph Node Biopsy for Ductal Carcinoma in Situ. Hung, P., Wang, SY., Killelea, BK., et al.[2020]

In a study of 98 women diagnosed with atypical ductal hyperplasia (ADH) through vacuum-assisted biopsy, the malignancy rate was significantly lower in patients who were monitored (5%) compared to those who underwent surgery (44%), suggesting that surveillance may be a safe option for low-risk patients.

The study found that the risk of cancer increased with the size of clustered microcalcifications and the number of ADH foci, indicating that these factors are important in assessing the need for surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of atypical ductal hyperplasia on vacuum-assisted biopsy of microcalcifications: External validation study of a decision tree selecting patients eligible for surveillance. El Sanharawi, I., Bataillon, G., Journo, G., et al.[2021]

In a study of 100 breast specimens, 37 cases were identified with columnar cell lesions (CCL), indicating that these lesions are relatively common and can occur alongside both benign and malignant conditions.

The presence of atypical columnar cell lesions was only found in malignant cases, suggesting that while most CCLs are benign, those with atypia require closer monitoring and potential surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Columnar cell lesions of the breast - significant or not? Seema, HS., Rajalakshmi, T.[2021]

In a study of 74 patients with pure ductal carcinoma in situ (DCIS), 7% had sentinel node metastases, indicating that some cases may have undetected invasive cancer.

Patients with metastatic sentinel node findings had a significantly larger median histological size of DCIS (50 mm) compared to those with negative sentinel nodes (18 mm), suggesting that larger tumors may be more likely to have metastasized.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumour-positive sentinel node findings in patients with ductal carcinoma in situ. Leidenius, M., Salmenkivi, K., von Smitten, K., et al.[2006]

In a study of 756 breast cancer patients who underwent neoadjuvant chemotherapy, the sentinel lymph node (SLN) identification rate was high at 92.7%, with 639 patients successfully having at least one SLN identified.

The study found that the mapping technique significantly influenced SLN identification, with the use of blue dye alone resulting in a lower identification rate (78.6%) compared to radiolabeled colloid (91.4%) and dual mapping agents (93.8%), highlighting the importance of optimal tracer use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting sentinel lymph node identification rate after neoadjuvant chemotherapy for breast cancer patients enrolled in ACOSOG Z1071 (Alliance). Boughey, JC., Suman, VJ., Mittendorf, EA., et al.[2023]

Sentinel lymph node biopsy (SLNB) in patients with clinically-detected ductal carcinoma in situ (CD-DCIS) was found to be technically feasible and highly accurate, with a 100% sentinel visualization rate and no false negatives in a study of 20 patients.

Out of the 20 patients, only 10% had a positive SLNB, and none showed additional metastasis in non-sentinel lymph nodes, suggesting that SLNB may be safely limited to those undergoing mastectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in clinically detected ductal carcinoma in situ. Al-Ameer, AY., Al Nefaie, S., Al Johani, B., et al.[2022]

A study involving 242 women and 10 surgeons revealed significant observer variation in clinical data recording, particularly in assessing axillary nodes (45% variation) and primary lesion size (55% variation), with discrepancies of over 2 cm in 20% of cases.

To improve consistency in future breast lesion trials, it is recommended to create clear proformas, define terminology, ensure universal access to these definitions, and conduct observer variation studies prior to the main trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observer variation in recording clinical data from women presenting with breast lesions. Report from the Yorkshire Breast Cancer Group. [2019]

Modern mammography is the most effective imaging method for detecting small breast lesions, which is crucial for improving long-term survival rates in breast cancer patients.

Despite strong recommendations for mammographic screening starting at age 40 by the American Cancer Society, many women and physicians are not adequately aware of its importance, highlighting the need for increased education and advocacy for regular screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and early diagnosis of breast cancer. McLellan, GL.[2005]

The relationship between different breast lesions and cancer risk is complex, but research has established guidelines that help assess risk based on patient factors like age and menopausal status, as well as characteristics of the lesions themselves.

Ductal carcinoma in situ (DCIS) is a key lesion in breast cancer risk assessment, and accurate diagnosis of DCIS is crucial for predicting the likelihood of future malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast lesions, pathology and cancer risk. Page, DL.[2019]

The SmartVax SMS-based system effectively monitored adverse events following immunization (AEFI) in a diverse population of 276 participants in Switzerland, achieving a high response rate of 90.3%.

The study found that 29.8% of immunization visits reported at least one AEFI, with the Shingrix® vaccine showing the highest rate of reactions, indicating that SmartVax can be a reliable tool for real-time vaccine safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study. Guedel, DS., Peters, IJ., Banderet, F., et al.[2021]

The VACC-Tool 2.0 mobile application significantly improved the classification of neuroinflammatory adverse events (NIAE) in children, successfully identifying 69% of cases that were missed or incorrectly coded in emergency department reports.

By using the VACC-Tool for longitudinal follow-up, additional NIAE were identified, demonstrating its effectiveness in enhancing the quality of safety information for pharmacovigilance and ensuring compliance with regulatory data standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study. Hoppe, C., Obermeier, P., Muehlhans, S., et al.[2018]

In a validation study of sentinel node biopsy (SN) for malignant melanoma in Southern Sweden during 2013, it was found that 4% of cases were not properly registered, indicating potential gaps in data collection.

The study suggests that some treating physicians may not be fully aware of the treatment recommendations for sentinel node biopsy in melanoma, which could impact the quality of care provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Validation of the Swedish melanoma registry shows limited misreporting. Incomplete for 4 percent of patients in sentinel node diagnostics]. Sundler, E., Werner-Hartman, L., Ingvar, C.[2017]

A 2-year study involving 88 specialist oncology nurses (SONs) showed that an educational intervention on pharmacovigilance significantly increased the reporting of adverse drug reactions (ADRs), with the intervention group reporting 82 ADRs compared to none from the control group.

The intervention made SONs 105 times more likely to report ADRs than the average nurse in the Netherlands, demonstrating that targeted education can effectively enhance ADR reporting and improve pharmacovigilance competence in healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions. Reumerman, M., Tichelaar, J., van Eekeren, R., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32620602/

Savi Scout® Radar Localisation of Non-palpable Breast ... Pooled analysis revealed an overall successful deployment rate of 99.64% and a successful retrieval rate of 99.64% using SSL. A statistically significant ...

2. ajronline.org ajronline.org/doi/10.2214/AJR.15.15962

Evaluation of the SAVI SCOUT Surgical Guidance System ... The final pathologic analysis found that lesion excision was successful, including five malignancies with negative margins. No patients required reexcision or ...

3. merit.com merit.com/products/clinical-data/scout-clinical-data/

SCOUT® Radar Localization Clinical Data Using Merit's SCOUT, surgeons can precisely target the affected tissue to pinpoint its location. View our clinical data & information.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2773160X24000199

Comparison of three new wireless non-radiation ... The objective of current systematic review and meta-analysis is to assess the clinical effectiveness between three new wireless non-radiation localisation ...

5. ar.iiarjournals.org ar.iiarjournals.org/content/40/7/3633

Savi Scout® Radar Localisation of Non-palpable Breast ... This systematic review and pooled analysis aimed to assess the efficacy of the Savi Scout® system for localisation of non-palpable breast cancer lesions. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8156313/

Reflector-Guided Localisation of Non-Palpable Breast ... In this study, we have evaluated one such system, SAVI SCOUT ® , in 63 consecutive patients. Our experience with this system supported its potential role in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03015649?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Cianna%20Medical,%20Inc.%22))&rank=2

NCT03015649 | Long Term Use of SAVI SCOUT: Pilot Study Thus, this pilot study will assess the performance of FDA-cleared SCOUT system over a longer duration prior to breast and/or axillary lymph node surgery.

8. withpower.com withpower.com/trial/savi-scout-for-breast-lesions-8c414

SAVI Scout for Breast Lesions · Info for Participants What safety data exists for SAVI Scout for Breast Lesions? The provided research does not contain specific safety data for SAVI Scout for Breast Lesions.

9. pennmedicine.org pennmedicine.org/treatments/savi-scout

SAVI SCOUT® Radar Localization for Lumpectomy SAVI SCOUT® makes lumpectomies for early-stage breast cancer easier by pinpointing tumors for more precise removal and more successful outcomes.