Proactive or Con?
By Beth W. Orenstein
Radiology Today
Vol. 26 No. 1 P. 20

Whole-body MRI screening scans are growing in popularity, while the debate over their value awaits research results.

Considering a preventive health full-body MRI? Options for these head-to-torso scans, which are meant to detect disease long before symptoms appear, are increasing. A number of companies that offer whole-body MRIs for a fee (usually $1,500 to $2,500) are opening new sites and expanding partnerships to increase access.

One of the pioneers in the business, Prenuvo, now has 17 locations in the United States and Canada and expects to open its first international site sometime this year (2025). In May 2024, New York-based Ezra announced it had partnered with Princeton Radiology to offer the scans in locations throughout northern and central New Jersey, adding to a growing number of established imaging partners such as RadNet and Rayus. As of the end of 2024, Ezra was live in 20 US cities across 70 imaging facilities, says Daniel Sodickson, MD, PhD, chief of innovation for the department of radiology at NYU’s Grossman School of Medicine and a scientific advisor for Ezra.

“There is a lot of money being poured into this,” says Matthew Davenport, MD, a professor of radiology and urology at the University of Michigan in Ann Arbor, who is skeptical of the scans’ value.

Whole-body MRI scans claiming to catch disease, especially cancer, when it’s in its earliest stages and most treatable was a topic of debate at RSNA 2024 in November. Sodickson was the panelist on the “pro” side. Taking the opposite side was Saurabh Jha, MBBS, an associate professor of radiology at Penn Medicine. Both had earlier published dueling opinion pieces in the Journal of the American College of Radiology. Sodickson argued that imaging could play a central role in proactive health monitoring but that effective, population-wide monitoring will require both supporting data and key changes in the traditional interpretation of scans to avoid overdiagnosis. Jha argued that the scans risk overdiagnosis and can result in a bevy of unnecessary follow-up biopsies and procedures.

Jha’s arguments reflect the ACR’s position. The ACR issued a statement in April 2023 that it does not believe there is sufficient evidence to justify recommending total-body screening for patients with no clinical symptoms, risk factors, or a family history suggesting underlying disease or serious injury. At the time, the ACR said it would continue to monitor scientific studies concerning the utility of total-body MRI for screening. As of October 2024, ACR spokesman Shawn Farley says the ACR’s statement “still stands.”

Linda Chu, MD, an associate professor in the Johns Hopkins Medicine department of radiology and radiological science, is not surprised by the growing popularity of whole-body MRI scans. “The business promises to find cancers early, which is something that we (patients, physicians) all want,” she says. The problem is balancing the limited sensitivity in detecting cancers with the small chance of detecting an incidental cancer early, she says.

“The whole-body MRI companies also have very successful marketing campaigns and endorsements from celebrities,” Chu adds. Celebrity influencers Kim Kardashian and Paris Hilton have both posted on social media about their whole-body MRI scans and encouraged others to do the same, equating the scans with being proactive about their health.

Chu believes the scans are not at all necessary for average-risk patients. However, she says, they may have a role for some high-risk patients, such as those with hereditary disorders such as Li-Fraumeni Syndrome. “These patients have very high lifetime risk of developing cancer, and they tend to develop cancer at younger ages,” Chu says. Current guidelines recommend whole-body MRI screening for patients with Li-Fraumeni Syndrome. Regular MRI screening is also recommended for patients with hereditary cancer syndromes such as Von Hippel Lindau, Birth Hogg Dube, and pheochromocytoma paraganglioma syndrome, but not necessarily wholebody MRI screening, Chu notes.

Research Underway
To date, little, if any, scientific evidence supports whole-body MRI scans for the general population. Most of the stories making headlines are anecdotal accounts of cancers that were highly treatable because they were found early in patients who underwent the scans. Some promoters have launched clinical research studies hoping to demonstrate that whole-body MRI can predict significant diagnoses in the general population, as well as identify new biomarkers of disease.

In July 2024, Prenuvo announced it was starting the largest research study of its kind for whole-body MRI screening with the goal of providing a foundational understanding of the nature of health and disease in the body. The study, which will take 10 years to complete, will enroll 100,000 participants. Currently, the scans are taking place at the Hercules Research Center in Boston.

“We are hoping to enroll more than 1,000 our first year,” says Daniel Durand, MD, Prenuvo’s CMO.

Because whole-body MRI scans are not covered by insurance, one criticism is that they are only available to people who can afford to pay $2,500 or more annually for them. The Hercules researchers hope to enroll at least 10%—and up to 50%— of participants who cannot easily afford the MRIs on their own. “The idea is to get [more than just wealthy] people enrolled in the study,” Durand says.

Chu does not foresee a time when these scans would be considered necessary screenings for most people as they age. “The benefits do not justify the costs, and I do not think they should be covered by insurance,” she says. “The money is better spent on evidence-based, age-appropriate screening and preventive health measures.”

Davenport argues that the research should precede the business model. “These companies are selling a product and promising a health benefit that they themselves do not know exists,” he says. “We have extensive experience with this approach, and the general result is harming a population and profiting the companies.”

Sodickson says Ezra, too, has been gathering data for about three years on the value of proactive whole-body MRI. This research is one of the things that convinced him to be an advisor to the company, he says. “Finally,” he says, “there was somebody who was interested in gathering this kind of data, which had not been gathered in any organized way until now, because most people assume they already know what it will show.” The goal is to document the actual risk of overdiagnosis as compared with correct diagnosis—in other words, to track the rate of false positive findings compared with true positive findings.

“I can cite stories of Ezra clients in whom cancer was found early and who were successfully treated before it advanced, but as a scientist, I know it’s not enough to rely on,” Sodickson says. “Unfortunately, it will take several years before enough evidence has been gathered to be statistically significant.”

Davenport says this is the problem with the current business models. He argues these companies are effectively performing research on a population for profit. However, Sodickson counters that such an assessment is premature, as profitability is still in the future, and a profit motive, while essential to assess, is not the sole driver of current proactive health initiatives.

Addressing Incidental Findings
Another criticism of whole-body MRI scans is that incidental findings may lead to aggressive overtreatment and high costs. “With proactive whole-body MRI scans, we likely will see many harmless incidental findings, such as thyroid nodules, liver lesions, renal lesions, etc, that are not adequately characterized on these whole-body MRI that will require further workup,” Chu says. She notes that these incidental findings can lead to additional focused imaging tests or invasive procedures, such as endoscopy and biopsy.

An additional concern is that if nothing is found, patients may opt to skip other US Preventive Services Taskforce-recommended screenings that have proven to be life-saving, such as colonoscopies for colon cancer or mammograms for breast cancer. “There are limitations to whole-body MRI in detecting certain common cancers, such as lung and colon, and a negative whole-body MRI screening may give patients a false sense of security,” Chu says.

Durand says whole-body MRI is not meant to “replace anything but rather to augment current guidelines.” He adds that only 14% of diagnosed cancers are found through a recommended gold standard screening test.

Sodickson says a better answer to the issue of overreaction to findings of potential disease may be active surveillance. “Active surveillance has become accepted medical practice for people with known risk of certain diseases throughout the United States,” Sodickson says. He believes that whole-body MRI scans could be used for active surveillance, too.

The detection of change is critical to assessing the potential aggressiveness of a disease such as cancer. Followup scans allow uncertain findings to be ruled out as issues of concern if they are substantially unchanged from baseline scans. Sodickson believes regular followup scans could help limit overdiagnosis while monitoring for significant changes.

“This has proven to be true for prostate cancer, breast cancer, lung cancer, and liver cancer,” Sodickson says. “There are a variety of cancers where the literature has shown that active surveillance is an effective practice, and a whole-body MRI protocol can be designed not as a catch-all but as a combination of established organ-specific protocols.”

Davenport says active surveillance is an accepted method in established clinical care and he supports it in that context. However, he says, it is not a justification for performing whole-body MRI in lowrisk patients. The psychological element is underestimated. It’s difficult, he says, for a patient, once he or she learns of a potential cancer, to wait it out and go every year or so for a scan to decide how to treat it. Whole-body MRI companies are recommending active surveillance as a solution to false-positive findings, but Davenport sees that solution as a moneymaker because patients must repeatedly return for additional scans that aren’t covered by insurance. Meanwhile, many patients will opt for biopsies and surgeries that create measurable harm, he says.

Future Considerations
Another development relevant to wholebody MRI is the use of AI. “Now, there are a number of groups who are using AI algorithms not just to detect a current cancer, but to predict a patient’s risk of developing cancer in the future,” Sodickson says. Various researchers have used mammograms to predict breast cancer risk, and a research team Sodickson leads at NYU is looking at more than 40,000 prostate MRI scans done over the past decade to train AI models to predict the risk of patients developing clinically significant prostate cancer in two to five years’ time.

“We are doing risk prediction not only based on one time point but also incorporating information from multiple scans at different times,” Sodickson says. “Our hypothesis is that the estimates will get better as more prior time points are included.”

Davenport likens proactive wholebody MRI to the health elixirs or curealls that were popular in the past. “Just because something is popular doesn’t mean it’s efficacious,” he says. “What it basically indicates is that there is an untapped need in the marketplace to feel like you’re proactively doing something about your health. That, of course, is extremely understandable. However, there is not one scientific publication that has demonstrated that these scans are helpful to health. Selling these scans requires persuading people that they are providing a health benefit when there is no scientific evidence that they do and strong scientific evidence to expect they will cause harm.” Davenport suspects the number of low-risk patients whose health is personally advantaged from performing a whole-body MRI is quite low, even when a cancer is detected early. This is because many cancers are low risk, especially those detected in low-risk patients, he says.

Chu notes that years ago, patients underwent whole-body screening with CT in hopes of detecting cancer early, but those CT screenings triggered many workups for incidental findings and their popularity faded quickly.

Sodickson, on the other hand, is concerned that a simple pro-con framing of the debate about whole-body MRI “is limiting our collective creativity.” He fears that, with the memory of ill-advised CT screenings in everyone’s minds, the radiologic community may be tempted to focus solely on the advisability of whole-body MRI as it currently exists, rather than pursuing innovations that may make imaging-based health monitoring a practical reality.

— Beth W. Orenstein of Northampton, Pennsylvania, is a freelance medical writer and regular contributor to Radiology Today.