FDA Approves Expanded Indication for CYTALUX Molecular Imaging Agent in Lung Cancer Detection


On Target Laboratories, Inc. announced that the US FDA has approved an expanded indication for the use of CYTALUX in lung cancer. According to the company, CYTALUX is the first and only targeted molecular imaging agent that illuminates lung and ovarian cancer intraoperatively, enabling the detection of more cancer for removal. The new indication will provide surgeons the ability to integrate CYTALUX into their treatment plan for adult patients with known or suspected lung cancer, where it previously was only approved for adults with ovarian cancer.

The label expansion is based on safety and efficacy evidence demonstrated in the ELUCIDATE Trial, a Phase 3, multi-center, single dose, open-label trial that investigated the use of CYTALUX in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.  

While surgery is a gold-standard treatment, up to 55% of people with lung cancer who undergo surgery with curative intent have a recurrence. During surgery for lung cancer, some lesions can be difficult for surgeons to visualize, particularly if they are small, beneath the surface of the lung, or a type of lesion called a ground glass opacity, which is becoming increasingly common as the rates of lung cancer screenings rise.

“Today’s approval of an expanded indication for CYTALUX marks an important step forward in the treatment landscape for lung cancer and for the more than 220,000 people in the U.S. who receive a lung cancer diagnosis each year,” said Chris Barys, President and Chief Executive Officer of On Target Laboratories, Inc. “We are proud to continue pioneering development of targeted intraoperative molecular imaging agents that illuminate cancers intraoperatively to enhance surgeons’ ability to see cancer in real time as they operate.”

“During the ELUCIDATE Trial, CYTALUX proved to be a valuable surgical tool with its ability to localize lung lesions that may have otherwise been missed,” said Dr. Linda Martin, Chief of Thoracic Surgery, University of Virginia School of Medicine. “CYTALUX has potential to become standard of care in thoracic surgery because of the safety and efficacy demonstrated in the trial.  It is an important tool for surgeons to consider for patients.”

CYTALUX was approved in November 2021 for use in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. CYTALUX is the first targeted molecular imaging agent that illuminates ovarian and lung cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV in as little as one hour before surgery, binds to folate receptors that are overexpressed in certain cancers4,5 and illuminates intraoperatively under near-infrared light.

Dog saves owner by sniffing out her cancer BEFORE she even knew she had it


Image: Dog saves owner by sniffing out her cancer BEFORE she even knew she had it

Dogs have a long history of being man’s best friend. But the story of a Newburyport Police Department officer and her blind dog from Massachusetts, doesn’t merely prove the bond between owner and pet but also proves that dogs are great at detecting illnesses.

Police officer Megan Tierney was reportedly at home with Dude, her blind border collie/Australian shepherd mix, when he started acting a little strange. According to her, she was lying in bed when Dude suddenly became focused on her chest area, placing a paw on her.

Tierney turned her attention on the spot Dude was touching and noticed a tissue swell. But to her surprise, a trip to the doctor confirmed that she has stage two triple negative invasive ductal breast cancer. And although finding out you have cancer is never an easy thing to swallow, the police officer said, “Dude found the lump, and we were never so happy because it just meant that we could get it where it was, rather than not knowing.”

It is known that dogs have a more heightened sense of smell compared to humans. Dude, being a blind dog, has greatly enhanced this particular sense which helped him detect the illness of his owner. Moreover, canines’ olfactory bulbs have 220 million scent receptors; 195 million more than that of humans.

According to dog-cognition researcher Alexandra Horowitz from Barnard College, dogs can smell odors in parts per trillion. For example, in a million gallons of water, dogs can detect if a teaspoon sugar was mixed into the water. This means their smelling abilities are 100,000 times better than ours. (Related: Dogs can smell lung cancer in humans.)

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One study, conducted by the Pine Street Foundation, reflects Dude’s exceptional skill. The study involved five dogs that were given breath samples of 31 breast cancer patients, 55 lung cancer patients and 83 healthy persons. All dogs were able to pinpoint which samples came from those who were ill, with approximately 90 percent accuracy.

Can dogs really smell cancer?

According to Tammana Khare of Dogs Naturally Magazine, because of the metabolic waste released by cancerous cells, a distinct smell is also released from the human body. This significant smell can be easily traced by dogs even during the earlier stages of cancer.

Other studies suggest that canines also have the ability to smell traces of skin cancer melanoma through skin lesions, and detect prostate cancer with just a urine sample from a person who is suffering from one.

“Not only does their sense of smell make cancer detection possible, but research suggests that dogs can be trained actively to sniff out the cancer, ” the canine expert shared. “In Berlin, a group of researchers trained some dogs to detect the presence of various types of cancer, including ovarian cancer, bowel cancer, as well as bladder cancer, skin cancer, lung cancer and prostate cancer,” Khane finished.

Although some remain to be with the whole idea of dogs being able to sniff out cancer and other illnesses, there are already some field experts who see a future where dogs will be directly used in patient care. More importantly, the special dog ability Dude exhibited helped his owner, Tierney, to manage her sickness and prolong her life.

Check out more amazing stories about man’s best friend on NaturalNewsPets.com.

Sources include:

Lifezette.com

PBS.org

 

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New Lasers Made of Blood Could Revolutionize Cancer Detection


Scientists from the University of Michigan have engineered a better way to track tumors with a laser that uses human blood.

LASERS — NOT THAT KIND BUT COOLER

Optofluidics, including the use of lasers, is not a new technology. Simply put, it is the application of some form of light to a liquid that serves as an amplifier, projected unto a reflective cavity. This technology is often used in medical research and surgery, like the use of infrared in scanning and imaging.

A group of researchers thought of a way to refine this technology, producing lasers with human blood.

It’s not exactly like the lasers in Star Wars, but it’s just as cool.

Human blood and an FDA-approved fluorescent dye called indocyanine green (ICG) made all the difference.  ICG has been used for decades now in imaging retinal blood vessels in ophthalmology. But without blood, “it doesn’t work at all,” says Xudong (Sherman) Fan, speaking to New Scientist. Fan is a professor in Biomedical Engineering at the University of Michigan.

BETTER TUMOR IMAGING

The researchers shone a form of infrared light on a reflective cylinder containing human blood with ICG as the amplifying material. The result was bright. The blood shone with the light, as ICG glows when mixed with protein in plasma.

Alfred Pasieka/SPL

With the light reflected back out, the researchers were able to observe cell structures and minuscule changes within the blood on a molecular level. The resulting fluorescence produced better imaging than current and existing techniques. Since ICG works well with blood, tissues that have a higher concentration of blood vessels — like tumors — will shine brighter.

Once the technology is refined to work on humans, this will be very useful in early cancer detection. “Eventually, we are trying to do it in the human body,” says Fan, but they are ensuring that the laser output is lower than recommended safety limits. “You don’t want to burn the tissue.”

Cancer detection: how the early bird catches the cause.


New screening methods will increase the chances of detecting certain cancers early, when the disease is most likely to respond to treatment

Woman smiling

Better chances: cancer treatment can be more effective when the disease is found early

When it comes to saving lives, early detection is a critical part of modern medicine. The sooner a problem is identified, the more effectively it can be treated.

That’s why screening for cancer is just as important as the development ofnew drugs and surgical interventions.

Bowel cancer is the third most common type of cancer in the UK and more than 100 people are diagnosed every day. Death rates have been falling over the past four decades but it still kills around 16,000 people a year.

So the development of a one-off, five-minute test that can not only diagnose bowel cancer in its early stages but could also allow doctors to take preventative measures to stop it developing in the first place is an extremely exciting breakthrough.

For the past 16 years, Professor Wendy Atkin has been investigating just such a test. Known as flexible sigmoidoscopy – but more commonly called ‘flexi-scope’ or bowel scope – it uses a tube called an endoscope with a tiny camera and light at the end to look for cancers in the bowel and spot very early signs of the disease.

Many bowel cancers develop from symptomless growths called ‘polyps’. If the flexi-scope finds any polyps they can usually be removed quickly and painlessly, there and then – stopping cancer from developing.

Using data from her trial, Prof. Atkin estimated that the test could prevent at least 5,000 people from being diagnosed with bowel cancer every year and at least 3,000 people from dying from the disease. That’s a reduction of 43 per cent in the fatality rate in people who take up the screening.

Cancer Research UK (CRUK) has pushed for this test to be incorporated into the national screening programme for bowel cancer and in 2010 the English government committed to achieving this. The charity is pushing for it to be implemented across the country as quickly as possible. The flexi-scope has the potential to prevent a third of bowel cancers in people tested by catching any polyps early.

Meanwhile, CRUK scientists are researching potential ways to detect cancerous cells in the body before they have had chance to wreak havoc. Ovarian cancer is one type where treatment methods are improving all the time, yet mortality rates remain high.

“We are still losing the majority of women diagnosed,” says Professor Usha Menon, a leading CRUK scientist. “Now we must focus on detecting the disease early enough to put those treatments to work, before it’s too late.”

This is where biomarker research – a technique where cancer cells or substances that indicate cancer are picked up in blood samples – is showing huge promise. Scientists have already identified one marker substance called CA125 that is naturally produced in the body at low levels. But in women with aggressive forms of ovarian cancer those levels are found to have risen dramatically.

At the moment, doctors use standard cut-off levels of CA125 in the blood to assess whether ovarian cancer might be present in women showing early symptoms of the disease. However, what’s really important is how individual women’s CA125 levels change over time – because what might be a normal level of the substance for one woman, could be a sign of something wrong for another.

Prof. Menon is the lead researcher on trials looking into a more personalised approach.

“At the moment, any rise in its levels won’t be flagged-up as a potential problem unless they’re beyond what is considered ‘normal’ for all women,” she explains.

“Now, we are starting to use the biomarker in a more bespoke way, so that any increase at all will be investigated.”

The trial currently involves 200,000 British women. The results look promising and final analysis will be completed next year. If this shows that looking at individualised biomarkers really can save lives, it could form the basis of a screening programme for ovarian cancer.

Says Prof. Menon: “If it works then we have a commitment from the NHS to start an early detection programme, in the same way that women are currently screened for breast and cervical cancer. It’s an exciting development, which could save countless lives by getting treatment for women who need it, before it’s simply too late.”