Currently this wait can take at least two weeks from a biopsy being taken in clinic. This typically means a total waiting time of at least six weeks from the initial GP appointment. The new research, published in Cancer, found the iKnife can give an immediate, accurate result when testing biopsies taken from the womb lining (endometrium) of women with abnormal bleeding. By providing a result within minutes, it could spare many patients that agonising fortnight of anxiety and uncertainty while they wait for the full pathology result to become available.
“The iKnife has the potential to completely revolutionise the way we manage women seen in the rapid access clinics, who have been referred with abnormal vaginal bleeding for potential diagnosis of endometrial (womb) cancer,” explains researcher Professor Sadaf Ghaem-Maghami from Imperial College London. “With its high diagnostic accuracy and positive predictive value, we could immediately reassure women of the very low likelihood of having cancer if the iKnife result is negative, and expedite further tests, scans and treatment for women whose biopsies indicate the presence of cancer. This could happen whilst awaiting confirmation from standard pathology.”
Fellow researcher Diana Marcus adds: “Everyone knows how stressful it is waiting or a diagnosis of cancer or ruling it out. The iKnife is an innovative tool to provide point of care diagnosis for endometrial (womb) cancer, reducing stress and shortening the time to start treatment.”
Womb cancer is the most common of the gynaecological cancers, and the fourth most common cancer in women. It affects 9,300 women and people with gynae organs every year in the UK alone. It accounts for 3% of all cancer diagnoses across the population, and the incidence is rising starkly, rising by 132% in the last 30 years! Increased age is a risk factor for the disease, but it’s important to be aware that womb cancer can affect you at any age – a quarter of women diagnosed with womb cancer are pre-menopausal.
For the three quarters of women with womb cancer who are post menopausal, the key symptom is post-menopausal vaginal bleeding. Any person experiencing post-menopausal vaginal bleeding should be referred to clinic following the urgent two-week referral pathway for suspected cancer. More than 90% of patients attending these rapid access clinics for a potential womb cancer do not have cancer. However, being referred for cancer investigations is an understandably stressful experience, even for patients who are ultimately given the all-clear. Previous research shows that women with suspected womb cancer experience high levels of stress and anxiety while being investigated and waiting for test results. For the majority who do not have cancer, the provisional result given by the iKnife could help to provide some much-needed reassurance and peace of mind.
The study, by researchers at Imperial College London, found the iKnife can differentiate between normal and cancerous womb tissue with a diagnostic accuracy of 89%. The tool has a specificity of 93% and a positive prediction value of 94%. This means that, when the iKnife made a provisional diagnosis of cancer, this was likely to match the final diagnosis.
‘Womb cancer has one ‘red flag’ symptom of post-menopausal bleeding that should always get checked out on a two-week referral from your GP. To wait a further two weeks for the results can be really hard for patients,” says Athena Lamnisos, CEO, The Eve Appeal.
“There are many reasons for abnormal vaginal bleeding after the menopause – womb cancer is just one of them. The ability to provide a diagnostic test that rules cancer in or out immediately, and with accuracy, could make such a positive difference,” she explains. “This Eve supported research has the potential to create a step change in faster diagnosis, and for the 90% of women with post-menopausal bleeding that isn’t cancer, a really effective way to put their minds at ease. We know how important this is for patients.”
150 women took part in the research, which took biopsies from the womb using a device called a Pipelle. Researchers then used the iKnife to analyse those samples. The tool works by cutting through tissue whilst delivering an electrical current, heating as it cuts. It then captures and analyses the vapour that is released, using a technique called mass spectrometry to spot any ‘cancer flags’ in the phospholipids in the tissue sample (phospholipids make up the outside of all cells, including cancer cells).
By testing biopsies from women with womb cancer, as well as biopsies from women with benign (non-cancerous) growths, the iKnife’s analysis software has built up a clear picture of what the outside of womb cancer cells are made of. The technology can now detect the phospholipids that are ‘flags’ for cancer and give an instant diagnosis.
Researchers say the results are highly encouraging and suggest the iKnife could be used in the clinic to provide a point-of-care diagnosis. Before this can happen, researchers need to carry out a multi-centre randomised, real-time trial, using the iKnife technology in the Rapid Access Clinic to make decisions about how to proceed. This can be done whilst awaiting results from pathology. Researchers can use this trial to measure how much more quickly patients receive cancer treatment when their care pathway involves using the iKnife. They can also analyse the levels of anxiety in women who find out their results immediately, compared to those who have to wait for their results using the standard pathway.
57-year-old Alison from West London was referred to the Rapid Access Clinic for womb cancer investigations earlier this year. “Thankfully I was one of the people with postmenopausal bleeding who was lucky enough to find out it wasn’t caused by cancer. It was really frustrating waiting for the results, which was almost three weeks for me,” she says.
“I was asked to go in person to receive the results too, which to me was a clear indication that it was bad news and I did have womb cancer. It was terrifying. I happened to have a call from another team, about another medical issue, the day before my appointment to go in and receive the results. They saw my results on file and mentioned that it was all-clear. This was a relief, of course, but it was irritating to know this information was just sitting on the system whilst I was waiting in a state of panic that I had cancer.”
For Alison, an immediate iKnife diagnosis could have significantly reduced that stress and anxiety. “It would have made such a difference to know straight away that I didn’t have cancer and not have to wait three weeks.”