Thousands of women with slow-growing cancers and benign breast nodules undergo needless invasive medical procedures every year. Currently, non-invasive medical diagnostic methods are not able to differentiate between benign and cancerous breast tumors.

A new “dye” pill, in the experimental stages, could change all of that. Fewer needless invasive procedures could save billions of medical system dollars. The pill will also reduce the fear associated with these procedures and the anxiety over awaiting results.

The newest CDC (Center for Disease Control and Prevention) data on breast cancer rates shows 236,968 women and 2141 men were diagnosed with breast cancer in 2014.

A breast cancer diagnosis may not be exactly what you might think it is. It is extremely difficult to distinguish between dangerous, fast growing types of cancer and the benign or malign types. There are types of cancer that grow so slowly that they will not affect a person throughout their entire lives. These cancers do not require treatment. The treatment will be worse for the patient than the cancer is.

Breasts can be especially difficult when it comes to diagnoses. The dense tissues of the breast can hide the existing tumors so they can go undetected for a very long time. They can even go undetected with regular breast exams and mammograms.

It is as a result of this lack of clarity in the original diagnostic process that creates the issue. In order to be certain of a diagnosis, doctors send patients for more tests and additional procedures until they can be absolutely certain. These procedures are quite invasive.

Very often biopsies are performed on perfectly harmless benign tumors. This puts pressure on the medical system. It creates anxiety for those being tested, and potentially creates complications and side effects.

A New and Better Way

It appears that recent research has developed a new concept when it comes to early breast cancer detection. This gives a new ability to discern between harmful and harmless breast lumps. The idea is that a “dye” pill lights up the problematic tissues. This is a significantly less invasive and less expensive procedure. Potentially, it is also more accurate, especially in the early phases of the diagnostic process.Patients find swallowing a pill to be far less stressful. Even if problematic tissues are found the treatment starts off on a better footing.

The researchers from the University of Michigan in Ann Arbor developed this revolutionary new “dye” pill. Once it has been ingested, the pill acts like a molecular imaging agent. This allows specialists to record significantly more precise data about the types and locations of tumors.

More Accurate and Safer than Current Breast Cancer Diagnostic Tools

Greg Thurber is the lead researcher. He describes the motivation for the protocol as, “We overspend 4 billion [dollars] per year on the diagnosis and treatment of cancers that women would never die from. If we go to molecular imaging, we can see which tumors need to be treated.”

Treating tumors that women would never die from sounds like it might not be as big a problem as it is. It is not just about being a waste of money and diagnostic resource time. The stressful nature of the tests are difficult for women, which can contribute to the recovery times from the biopsies, let alone any harmful cancers.

Treating harmless tumors with powerful drugs like chemotherapy puts lives at risk.

When Tumors Need to Be Treated

When the cancer is found to be harmful, treatment must usually begin very quickly. A lag time created by extra diagnostic testing, and recovery time in the patient, mean the therapies start much later. This gives that harmful cancers time to grow between initial discovery and the beginning of therapy.

Harmless Tumors That Do Not Require Treatment

Many times, women are asked after their normal screening mammography to undergo a biopsy because there is a questionable finding. These biopsies are physically and emotionally invasive. In addition, they are expensive. Of course, no doctor can leave a questionable finding without further testing. This is why the “dye” pill is so revolutionary.

The Research

The research team conducted experimental studies on mice. This is yielding promising results so far. A detailed account of the findings of their research is published in the Molecular Pharmaceutics journal.
The “dye” pill contains a remarkable “dyeing” agent to mark the tumors. It responds only to a molecule present in tomor cells. It marks blood vessels feeding the tumor growth, plus any inflamed tissues.

Under standard infrared light the “dye” can be seen without any x-rays or other riskier scanning systems. Infrared light is the unseen light just beside the visible light spectrum, that we experience as heat.

Cancer Can’t Hide

The “dye” marks the tumors with complete accuracy. This makes it possible to locate the tumor precisely. It makes it possible to determine exactly where it ends, and how it is being fed by blood vessels.

The marker also shows different types of tumors by differentiating the molecules that are found on the tumor cell surface. This allows specialists to quite easily differentiate between the benign and malignant nodules. It also makes it possible to assess cancerous tumor types. Since the cancerous tumor types will be determined far more rapidly, the treatments can begin sooner. The expectation is that this could positively influence survival rates.

There are other injectable infrared dyes available, but this specific dye pill is a significantly safer tool. This dye provides additional benefits because some patients have severe adverse reactions to the dyes that are delivered by injection.

The Task Ahead

Pills delivering macromolecules to tumors are not new. They have been researched, but have eventually all proved to be inefficient in the clinical trials.

There are a number of challenges that must be overcome to design a new method to deliver the chemical agents where they need to go.

The body has gateways to block agents from passing into the bloodstream that must be bypassed.

The research team at the University of Michigan in Ann Arbor has admitted that these obstacles are particularly complex.

Opposite Properties Needed to Find the Tumors

Essentially they are dealing with opposing properties. If you want to make a molecule that is easily absorbed into the bloodstream from the digestive tract, it needs to be “small and greasy”. Imaging agents that will mark the tumors need to be water-soluble and much larger. These are exactly the opposite properties.

The current “dye” pill is based on the core design of a cancer drug that failed phase II clinical trials. The therapeutic cancer agent was not effective, but the pill’s composition was ideal to carry macro molecules into the bloodstream. This allows the macro molecules to search the body for any existing tumors. The pill carries the molecules to bind to the target tumors, but it doesn’t have any therapeutic action. This is perfect for imaging.

In this study, Thurber and his team of researchers worked with the mouse model for breast cancer. They are pleased that the pill has worked exactly as they expected. The “dye” pill delivers the infrared dye to any relevant tumors and then marks all the nodules.

This macro molecule contained within the pill has survived the gateways of the body keeping it from the bloodstream. It survived the acidic environment of the stomach, and was not cleansed from the blood by the liver.

This “dye” pill eventually passed into the bloodstream and does its work finding, marking and identifying tumors.

This is a huge step forward in breast cancer diagnostics with the potential to save over $4 billion dollars in unnecessary, invasive, stressful medical tests and treatments. It also could bring treatments to the women who need them sooner, leaving the medical budget for therapies instead of diagnostic tests.