FDA-Approved New Imaging Drug: Cancer Detection

Breast cancer is one of the most common cancers among women worldwide. In many patients diagnosed at an early stage, breast-conserving surgery, known as lumpectomy, is an important treatment option. During lumpectomy, cancerous tissue is removed while most of the breast is preserved. However, one of the most critical points in this procedure is accurately evaluating whether all cancerous tissue has been removed.

The U.S. Food and Drug Administration has approved a new imaging drug that may help surgeons in this area. Pegulicianine, known as Lumisight, helps make cancerous tissue that may remain in the surgical cavity more visible through fluorescence imaging after the tumor is removed during lumpectomy. This development is considered an important step toward more precise tissue evaluation in breast cancer surgery.

What Is Lumpectomy?

Lumpectomy is a breast-conserving surgical method in which cancerous tissue and a small amount of surrounding healthy tissue are removed in breast cancer treatment. The aim of this procedure is to remove the cancerous area while preserving as much of the breast as possible. It may be an important treatment option for suitable patients, especially in early-stage breast cancer.

After lumpectomy, additional treatments such as radiotherapy may be considered in many patients. The treatment plan is determined according to tumor type, stage, surgical margins, lymph node status, the patient’s general health, and the oncology team’s evaluation.

Why Is Detecting Cancerous Tissue After Lumpectomy Important?

Whether cancer cells remain around the tumor removed during lumpectomy is important for treatment success. The goal is to have clean surgical margins, meaning no cancer cells are found at the edges of the removed tissue. If cancerous tissue is detected at the surgical margin, an additional surgical procedure may be required.

Cancerous tissues may not always be clearly visible to the naked eye. Some cancer cells may remain at a microscopic level or may look similar to surrounding tissue. Therefore, using imaging methods that provide more information during surgery may help the surgeon plan tissue removal more precisely.

What Is Lumisight Approved By The FDA?

Lumisight is a fluorescence imaging drug whose active ingredient is pegulicianine. It is used in adult breast cancer patients during lumpectomy to help evaluate whether cancerous tissue remains in the surgical cavity after removal of the primary tumor. The drug is administered intravenously before surgery and works together with specific imaging systems.

Pegulicianine is designed to help visualize signals associated with biological activity in cancerous tissue. Approved fluorescence imaging devices such as the Lumicell Direct Visualization System visually present these signals to the surgeon. In this way, the surgeon may better evaluate some suspicious areas that could otherwise be missed during the operation.

How Does The Lumicell Direct Visualization System Work?

The Lumicell Direct Visualization System is a fluorescence imaging system used together with Lumisight. It detects fluorescence signals in the surgical cavity and helps show suspicious cancerous tissue areas. This system supports the surgeon in directly evaluating the resection cavity after lumpectomy.

This technology does not replace standard surgery and pathology evaluation. It should be considered more as an auxiliary method that provides additional information during surgery. The surgeon’s clinical assessment, pathology results, and multidisciplinary treatment plan remain the main decision-making mechanisms.

The Importance Of The New Imaging Drug In Breast Cancer Surgery

The main goal in breast cancer surgery is to remove cancerous tissue as completely as possible while avoiding unnecessary removal of healthy tissue. This balance is not always easy. Incomplete removal of cancerous tissue may increase the likelihood of repeat surgery, while removing more tissue than necessary may affect aesthetic and functional outcomes.

Lumisight and the related imaging system may help the surgeon make more informed decisions during surgery. Making cancerous tissues more visible may contribute to surgical margin assessment and support the decision to remove additional tissue in some patients.

Can It Reduce The Risk Of Repeat Surgery?

If cancer cells are detected at the surgical margin after lumpectomy, the patient may need another operation. Repeat surgery may prolong physical recovery, increase psychological burden, and delay the treatment plan. Therefore, removing cancerous tissue correctly during the first operation is very important.

New imaging technologies may have the potential to reduce the likelihood of repeat surgery by helping suspicious residual tissues be noticed better during the operation. However, this effect may not be the same for every patient. Results may vary depending on tumor type, surgical technique, the patient’s anatomy, and the treatment team’s evaluation.

Who Can Use Lumisight?

Lumisight is an imaging drug approved for use during lumpectomy in adult breast cancer patients. However, it cannot be said to be automatically suitable for every breast cancer patient. The decision to use it should be made according to the surgical team, oncology team, and the patient’s clinical condition.

The patient’s tumor characteristics, surgical plan, additional diseases, allergy history, and suitability for the imaging system should be evaluated. Therefore, patients should always consult their own treatment team when seeking information about such new technologies.

Does The Imaging Drug Replace Treatment?

Imaging drugs such as Lumisight are not medicines that treat breast cancer. These products are used to help detect cancerous tissue during surgery. In other words, the purpose is to provide additional visual information to the surgeon.

Breast cancer treatment is often carried out with a combination of different approaches such as surgery, radiotherapy, chemotherapy, hormone therapy, targeted therapies, or immunotherapy. The imaging drug should be considered only as an auxiliary tool in the surgical stage of this plan.

What Does This Mean For Patients?

FDA approval shows that more precise and technology-supported approaches are developing in breast cancer surgery. For patients, such innovations may contribute to clearer surgical planning and, in some cases, reduce the need for additional surgery.

However, as with every new technology, this method should be used with appropriate patient selection. Patients should evaluate whether Lumisight or similar imaging methods are suitable for their treatment process together with breast surgery, medical oncology, and radiation oncology teams.

Why Is Early Diagnosis Critical In Breast Cancer Treatment?

Early diagnosis in breast cancer is one of the most important factors that increases treatment success. Through regular screening, breast awareness, and physician controls, many cancers can be detected at earlier stages. In patients diagnosed early, options such as breast-conserving surgery may be considered more often.

Breast cancer symptoms may include a lump in the breast, nipple discharge, skin dimpling, redness, orange peel-like skin appearance, nipple inversion, and swelling in the armpit. These symptoms do not always mean cancer; however, they require specialist evaluation without delay.

Why Is Regular Follow-Up Important For Breast Health?

Regular follow-up in breast health is important not only for people diagnosed with cancer but also for those in risk groups or those with symptoms. Family history, genetic predisposition, age, hormonal factors, and lifestyle may affect breast cancer risk.

Regular physician control, appropriate imaging methods, and a personalized screening plan help protect breast health. In people diagnosed with breast cancer, post-surgical follow-up, pathology results, and additional treatment planning are important parts of treatment success.

Online Doctor Consultation With Happ Health For Breast Health

Breast cancer surgery, lumpectomy, pathology results, or questions about breast health may cause anxiety. In this process, reaching accurate information, evaluating symptoms, and learning which specialty to consult are important.

As a digital health platform, Happ Health makes access to online doctor consultations easier from home or remotely. You can receive online doctor support for breast health, the post-surgical process, follow-up planning, or the need for a second opinion, and plan your healthcare process more consciously.

References

• FDA - FDA Approves Imaging Drug To Assist In Detection Of Cancerous Tissue Following Lumpectomy
  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-imaging-drug-assist-detection-cancerous-tissue-following-lumpectomy
• FDA - Lumicell Direct Visualization System
  https://www.fda.gov/medical-devices/recently-approved-devices/lumicell-direct-visualization-system-dvs-p230014
• FDA - Lumisight Prescribing Information
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214511s000lbl.pdf
• American Cancer Society - Breast-Conserving Surgery
  https://www.cancer.org/cancer/types/breast-cancer/treatment/surgery-for-breast-cancer/breast-conserving-surgery-lumpectomy.html
• National Cancer Institute - Breast Cancer Treatment
  https://www.cancer.gov/types/breast/patient/breast-treatment-pdq
• BreastCancer.org - Lumpectomy
  https://www.breastcancer.org/treatment/surgery/lumpectomy