Innovative combination of light and ultrasound could help catch ovarian malignancy early

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A team of physicians and researchers from the Washington University School of Medicine in St. Louis has recently developed a ‘hopeful technique’ that combines ultrasound and photoacoustic technology to evaluate and diagnose malignant ovarian tumors at an early stage.

Ovarian malignancies are often diagnosed at a late stage because there are no specific signs and symptoms and no specific screening test for diagnosing ovarian cancer. Only 15% of ovarian cancers are detected at early stages.

The American Cancer Society estimates that about 22,240 women will receive a new diagnosis of ovarian cancer and about 14,070 women will die from ovarian cancer in the year 2018.

The researchers recently conducted a pilot study using co-registered photoacoustic tomography with ultrasound to evaluate ovarian masses in 16 patients at the School of Medicine and Barnes-Jewish Hospital. The results were recently published in the journal Radiology.

The team involving Quing Zhu, professor of biomedical engineering in the School of Engineering & Applied Science created a sheath using optical fibers that encases the standard transvaginal ultrasound probe. The optical fibers are connected with a laser source.

As the sheath is introduced in the vagina, the laser light penetrates the vaginal wall to get absorbed by the tumor to generate sound waves to reveal information about tumor vasculature and sO2 inside the ultrasound visible ovaries.

A normal ovary is not highly vascular and contains a lot of collagen tissue, but a malignant tissue is highly vascular because of neoangiogenesis. Using this multispectral photoacoustic imaging, the team looked at 26 ovarian masses from 16 participants that included nine invasive epithelial ovarian cancers (six serous carcinomas and three endometroid adenocarcinomas), three other tumors (two borderline serous tumors and one sex cord-stromal tumor), and 14 benign and normal (hereafter referred to as benign/normal) ovaries.

The researchers used two biomarkers to study the ovaries: relative total hemoglobin concentration (rHbT), which is directly dependent on the tumor angiogenesis, and mean oxygen saturation (sO2). The rHbT was almost two times higher for invasive epithelial cancerous ovaries as compared to normal ovaries P = .01) and the mean sO2 of invasive epithelial cancers, and the borderline and stromal tumors, was 8.2% lower than that of benign/normal ovaries (P = .003).

“Physicians are very excited about this because it might bring significant change into current clinical practice,” Zhu said. “It is very valuable to detect and diagnose ovarian cancers at early stages. It is also important to provide information and assurance to patients that there is no worry about their ovaries, instead of removing a patient’s ovaries. This technology can also be valuable to monitor high-risk patients who have increased risk of ovarian and breast cancers due to their genetic mutations. The current standard of care for these women is performing risk reduction surgeries to remove their ovaries at some point, which affects their quality of life and causes other health problems.”

Encouraged by the results of the pilot study, the team is gearing up to validate the findings in larger subjects and has applied for funding.

Here is a short video showing Dr. Zhu explaining the technology

Abstract in Radiology Journal

News Release by Washington University in St. Louis

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FDA issues warning against laser and energy-based “vaginal rejuvenation” procedures

Despite their sudden hype and growing popularity, there is no evidence that so-called “vaginal rejuvenation” therapies are either safe or effective, the U.S. Food and Drug Administration warns in a statement today.

The procedures which use energy-based devices—laser and radiofrequency waves both, to reshape and firm the vaginal tissue claim to treat many genitourinary conditions like urinary incontinence, vaginal atrophy, and dyspareunia.

In addition to treating the above conditions, manufactures and healthcare provider also assert that it improves the sex lives of perimenopausal and menopausal women.

In the statement released on Monday FDA Commissioner, Dr. Scott Gottlieb stated, “These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.” 

The procedures are known to cause vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain. The full extent of damage is not recognized as the devices have not been approved for “vaginal rejuvenation.”

FDA has approved and cleared these procedures for destruction of precancerous lesions of cervix and vagina and vaporization of condylomas (genital warts). But the safety and effectiveness of these devices haven’t been studied and confirmed for “vaginal rejuvenation.”

In some cases, women who have undergone treatment for breast cancer are offered these treatments under the false assertion of mitigating their symptoms of early menopause.

FDA has recently notified seven device manufacturers for concerns about the inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen.

They have 30 days to address the FDA's concerns, and if they fail to do so, FDA may consider enforcement measures.

The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions," Dr. Gottlieb said.

"These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options," he explained.

He further advised, "Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options."

Dr. Gottlieb further assured that FDA will carefully monitor reports of problems associated with "vaginal rejuvenation" procedures and will keep the public informed.

He urged that patients who have suffered adverse effects with the use of these devices should report the complications to  MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Dr. Vanessa Mackay, from the UK's Royal College of Obstetricians and Gynaecologists (RCOG), said: "There is no evidence to suggest that non-surgical 'vaginal rejuvenation' devices are effective in improving vaginal muscle tone or reshaping vaginal tissue. If women are concerned about the appearance or feel of their vagina, they should speak to a healthcare professional. It is important to remember, however, that every woman's vagina is different. Labia are as individual as women themselves and vary in appearance and color.

"To strengthen the muscles around the vagina, women are encouraged to try pelvic floor exercises which can help to improve muscle tone and sensitivity during sex."

FDA Statement

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