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

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a device that helps surgeons accurately locate and remove breast tumors. It uses a small implant that sends signals to a handheld tool, guiding the surgeon during surgery. The target group is patients with breast tumors needing precise removal.

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 data supports the idea that SAVI Scout for Breast Lesions is an effective treatment?

The available research does not provide specific data on the effectiveness of SAVI Scout for Breast Lesions. Instead, it focuses on sentinel lymph node biopsy (SLNB) for ductal carcinoma in situ (DCIS) and other related topics. Therefore, there is no direct evidence from the provided information to support the effectiveness of SAVI Scout for Breast Lesions compared to other treatments. ^{1 2 3 4 5}

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. The studies focus on adverse event detection tools, vaccine safety surveillance, dermatology drug safety, oncology nurse training for adverse drug reaction reporting, and immunization adverse event monitoring, none of which directly address SAVI Scout or its safety data. ^{6 7 8 9 10}

Is the treatment SAVI Scout® a promising treatment for breast lesions?

Yes, SAVI Scout® is a promising treatment for breast lesions because it helps in accurately locating and removing small breast lesions, which is important for early detection and treatment of breast cancer. ^{11 12 13 14 15}

Research Team

Tanya Moseley, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tumour-positive sentinel node findings in patients with ductal carcinoma in situ. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Factors affecting sentinel lymph node identification rate after neoadjuvant chemotherapy for breast cancer patients enrolled in ACOSOG Z1071 (Alliance). [2023]

3. Sweden pubmed.ncbi.nlm.nih.gov

[Validation of the Swedish melanoma registry shows limited misreporting. Incomplete for 4 percent of patients in sentinel node diagnostics]. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Sentinel Lymph Node Biopsy for Ductal Carcinoma in Situ. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in clinically detected ductal carcinoma in situ. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study. [2021]

7. New Zealand 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. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Monitoring adverse events following immunisation in developing countries: experience from human papillomavirus vaccination demonstration projects. [2013]

10. England pubmed.ncbi.nlm.nih.gov

How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting. [2021]

11. England 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]

12. Ireland 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. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Screening and early diagnosis of breast cancer. [2005]

14. India pubmed.ncbi.nlm.nih.gov

Columnar cell lesions of the breast - significant or not? [2021]

15. United States pubmed.ncbi.nlm.nih.gov

Breast lesions, pathology and cancer risk. [2019]