The rise of theranostics: Part 3 -- What is a theranostics center?

With therapeutic radiopharmaceuticals coming to market quickly and available to smaller institutions around the U.S., those interested in expanding care using emerging radioligand therapies (RLTs) may be deciding on how to start or where to expand.

Eliot Siegel, MD; Stanislav Spiridonov, MD; Nathan Gee, MD; and Anthony Chang, PhD, are among a niche gathering of early adopters, entrepreneurial physicians, medical physicists, and investors with a sweet spot for nuclear medicine, diagnostic radiology, and radiation oncology.

For this third in a series of articles covering the rise of theranostics, AuntMinnie.com asked several of those at the forefront to discuss freestanding theranostics center development, their roles, and some of the obstacles they've encountered with introducing the new model of care.

Concierge medicine

Having spent the greater part of the past three decades in the department of diagnostic radiology at the University of Maryland School of Medicine and as chief of radiology and nuclear medicine for the Veterans Affairs Maryland Healthcare System, Eliot Siegel, MD, has been watching the practice of theranostics become attractive for wider adoption outside of large academic medical centers (See Part 2 of the rise of theranostics series).

Siegel co-founded United Theranostics, a private, freestanding theranostics center that's becoming a network after just a few years in existence. Not long after the first United Theranostics center emerged from Advanced Molecular Imaging and Therapy, just prior to the pandemic era in Glen Burnie, MD, the practice is quickly evolving into a more concerted effort to design theranostics centers from the East Coast to the Southeast and Southwest, and subsequently throughout the U.S., Siegel told AuntMinnie.com. For those who are unclear about what a theranostics center is, AuntMinnie.com asked Siegel to explain.

Eliot Siegel, MD, of United Theranostics defines a freestanding theranostics center.

"My vision of a theranostic center includes a flagship facility that has a PET/CT scanner, a SPECT/CT scanner, and then multiple rooms for infusions of radiopharmaceuticals," Siegel explained. However, he noted that there are many different types of theranostics implementations.

"Somebody on the other end of the spectrum might say a theranostics center represents a clinical practice where patients are administered a radiopharmaceutical, with any diagnostic imaging sent out to those who do diagnostic imaging, and then these patients are sent back for clinical care to their medical oncologist for all follow-up," he added.

"But the model that we have is on the opposite end of the spectrum, where the idea is that the theranostics physicians, whether they're nuclear medicine physicians or radiologists, actually temporarily become the patient's subspecialty medical oncologist," Siegel said. "As part of becoming the patient's medical oncologist, for example, we end up taking responsibility for those 36 weeks of Pluvicto therapy for all aspects of patient care while coordinating closely with a patient’s medical and/or radiation oncologists."

For Siegel, a theranostics center includes the diagnostic imaging equipment, plus the ability to infuse and do detailed dosimetry to allow precision or personalized therapy, plus the ability to be able to see patients for consultations along the lines of their treatment. "We think all of those things are really necessary for optimal patient care." He added that United Theranostics has been developed with the intention to participate in clinical trials.

Large practice extension

At ARA Diagnostic Imaging's advanced imaging center in Austin, TX, Stanislav Spiridonov, MD, shifts from the needs of clinical duties, such as interpretation of general radiology exams, nuclear medicine studies, PET, performing light interventional procedures, and treating theranostics patients, to practice administration. Spiridonov is also vice president of the private practice group and assistant professor at Dell Medical School of University of Texas at Austin.

Spiridonov said theranostics has played a long-term role at ARA Diagnostic Imaging, a Radiology Partners practice since 2019 but one with a relatively large academic arm. The midtown center has been in operation since the 1950s and currently operates 17 outpatient imaging centers across the greater Austin metropolitan area, serving 24 area hospitals. However, just one location serves as the ARA Theranostics Center, Spiridonov explained, and it's growing.

"The cadence of discovery in the field of theranostics has increased significantly in the past four years," Spiridonov told AuntMinnie.com, adding the location was uniquely positioned to grow with the approvals and availability of Pluvicto for prostate cancer in part because of its established advanced interventional radiology suite and multimodality imaging capabilities.

Stanislav Spiridonov, MD, from ARA Diagnostic Imaging and Dell Medical School at the University of Texas at Austin talks theranostics milestones.

"We were already performing multimodality imaging here, including theranostics-related imaging, PET, PET/CT, and it's also unique since we were performing advanced interventional radiology procedures including Y-90 prostate artery embolization and uterine fibroid embolization. This facility was perfect for the purpose of putting a theranostics center in a pre-existing center because we had the staff here, we had the knowledge base, and it was centrally located. Patients had given us feedback that undergoing therapy in the same place where they were having their imaging done was a big plus for them."

Spiridonov's dual-board certification in diagnostic radiology and nuclear medicine serves the practice well, he said, adding that a nuclear medicine residency at Dell Medical School exposes young physicians to theranostics as part of the program.

Spiridonov also said that theranostics has increased interdisciplinary conferences, and decisions are made as a team rather than a single individual clinician making a decision for the patient. The ARA Diagnostic Imaging theranostics center was designated as a Center of Excellence in 2022 by the Society of Nuclear Medicine and Molecular Imaging.

Clinical trial destination

In Michigan eight years ago, Anthony Chang, PhD, envisioned a comprehensive, large-scale center for theranostics. Now equipped to manufacture radiopharmaceuticals, including novel theranostics agents, BAMF Health is emerging as a high-efficiency clinical trial platform. BAMF stands for Bold, Advanced Medical Future.

Located in the Doug Meijer Medical Innovation Building on the Medical Mile of Grand Rapids, MI, BAMF Health's flagship assets include two medical-grade cyclotrons that operate alongside the molecular imaging clinic and molecular therapy clinic.

Chang insists that BAMF Health is not a clinical company. BAMF is a technology company determined to design and develop the most effective and efficient infrastructure for large-scale theranostics.

"We're trying to develop a high-throughput, high-quality comprehensive diagnostic center allowing us to offer a wide variety of radiopharmaceuticals at a commercial scale, at affordable prices," Chang told AuntMinnie.com. "We know there are a lot of radiopharmaceuticals for a wide variety of diseases," he said, adding that running clinical trials in a large, multifaceted facility such as BAMF presents the opportunity to "really understand and optimize how to use these kinds of drugs efficiently."

Anthony Chang, PhD, of BAMF Health describes the technological infrastructure of BAMF in Michigan.

BAMF Health was the first site in the world to test a novel radiopharmaceutical for pancreatic cancer imaging, as a clinical trial partner to pharmaceutical company Japan-based Nihon Medi-Physics Co. Ltd., led by Harshad Kulkarni, MD, as principal investigator.

Chang added that BAMF can launch and enroll patients for clinical trials in one to two months.

"That's the power we can achieve," Chang said. "We definitely can make the whole process more efficient," he said, adding that BAMF is also committed to advancing molecular targeted radiation therapy through the application of precise dosimetry.

Chang also said BAMF is getting a head start on new directions in Alzheimer's imaging that rely on special amyloid tracers.

Roadblocks

Nathan Gee, MD, nuclear medicine and molecular imaging subspecialty lead for Radiology Partners' Clinical Value Team, reflected on the obstacles that practices may encounter, his own (Ohio-based Columbia Radiology) included.

"I've spent a lot of time trying to help pull resources together to help any practice that wants to get into theranostics so that they'd be able to successfully do that, but I've learned from my own experience that it's costly, and there are a lot of moving parts, and there are definitely some roadblocks to initiating the treatment within a practice," Gee told AuntMinnie.com, adding that theranostics is underserved in his geographic area.

Columbus Radiology, like many other imaging centers, is contracted to serve local hospitals, in this case throughout Ohio.

"We have to get buy-in from the hospital and that can be a process, especially as several of our hospital partners are part of larger healthcare systems," Gee explained. "There are multiple layers of decision-making and bureaucracy. The reality is the therapies are very expensive. You can collect on the billing side, but you have to have upfront money to start doing this, and it's not an insignificant budget item."

Another obstacle is that even though Columbus Radiology has a stable of over 100 radiologists, only two full-time radiologists are trained in nuclear medicine.

"To get therapies going at all the sites, all the hospitals that may be interested, is hard with so few people who are capable and interested," Gee said. "We know that if nuclear medicine physicians step aside and they don't want to do it, other people are going to take over. A lot of radiation oncologists have started to become interested in performing these therapies and especially in places where they don't have anyone available in nuclear medicine."

Theranostics is "cutting edge" in the nuclear medicine world, and Gee is among those radiologists who subspecialize in nuclear medicine and who enjoy both diagnostics and treatment. His advice to those who are interested in adding theranostics is to start early. As Pluvicto for prostate cancer became available, he explained, Novartis showed preference to those who were already using Lutathera by not taking on any new sites for Pluvicto.

"There was this early time where the excitement had to be slowed down, and we lost a bit of momentum trying to get things onboarded because of supply issues," Gee said. "Now sites are now getting cycled up to start doing it." Gee also said different hospitals can be in different stages of commitment in relation to offering theranostics with their contracted radiology group.

Nathan Gee, MD, of Columbus Radiology describes some of the obstacles of getting established with theranostics.

"This is going to be transforming how we can use radiation in treatment for various cancers because we can effectively or hopefully effectively treat metastatic disease with cancer in a way that you just can't do with external beam radiation, but it's hard to get enough people in the pipeline early enough to help carry that momentum," Gee concluded.

New medical specialty?

The American Board of Medical Specialties does not recognize "theranostics" as a specialty or subspecialty in its recently updated board certification report. However, the practice of theranostics has already become a medical specialty, Siegel asserts. He predicts theranostics will continue its rise and evolve, eventually under its own umbrella.

Theranostics practice insights
In a sampling and survey of nuclear medicine sites, 14% indicated they perform theranostics procedures, with 49% of nuclear medicine departments considering adding capacity for theranostics-related procedures.
Procedures 55% of theranostics sites used I-131 for cancer therapy. 50% used Lu-177 PSMA. 49% used Y-90 microspheres. Additionally, 65,000 theranostics procedures were performed with strontium-89, 64,000 with samarium-153 EDTMP, and 58,000 with Y-90.
Source: IMV Market Research, 2024 NM Market Outlook Report* (This report summarizes the results of IMV Medical Information Division’s 2024 survey of U.S. hospitals and cardiology practices that perform nuclear medicine [NM] procedures using fixed SPECT/CT, SPECT, and planar-only cameras.)

"My philosophy about a theranostics provider is somebody that takes total and comprehensive care of all of the aspects of the radiopharmaceutical therapy for a particular cancer," Siegel added. "For prostate cancer therapy for example, that might be six treatments over 36 weeks with the theranostics practitioner really taking responsibility for all aspects of the patient's care and then turning the patient back to the referring medical oncologist at the end of the therapy."

That means collecting all the data, lab and genomic evaluation, previous therapy data, and all medication data, "just as though we were becoming their temporary primary practitioners of cancer care during that period of time that we're treating the patients."

"It also means that we do our own interpretations with our own studies as radiologists or nuclear medicine physicians," he said. "We're doing PET/CT imaging and we're doing SPECT imaging for dosimetry. We become the physicists who determine the doses after we give the therapies using SPECT/CT to be able to fine-tune and personalize the doses for future treatments."

"We also to a large extent become the practitioners that are advocates for the patient and also practitioners who try to look at possibilities of combination therapies working closely with radiation oncologists, working closely with medical oncologists and other practitioners to take care of the patient during the time that the patients are under our care.

"It's really important to provide that comprehensive care to avoid what I think is a problem in medical care in general, which is fragmentation, which we see so often today," Siegel concluded.

Is theranostics ready for prime time?