Veriton SPECT/CT for Gamma Camera Comparison

Overseen By Michael K O'Connor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Unable to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging system called Veriton SPECT/CT. The goal is to determine if it provides clearer images than traditional gamma cameras used in nuclear medicine exams. Researchers seek adults already scheduled for a nuclear medicine exam who can lie still on the imaging table for up to 40 minutes. Meeting these criteria may make you a suitable candidate to help evaluate this new system's effectiveness. As an unphased study, this trial offers a unique opportunity to contribute to advancements in medical imaging technology.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this gamma camera is safe?

Research has shown that the Veriton SPECT/CT system is FDA-approved, indicating it meets specific safety standards. This new imaging system uses 12 small cameras to capture images, and studies suggest it provides better image quality with less radiation than older systems.

Testing has confirmed the system's safety, meeting all necessary regulations. Available studies have not reported any specific negative effects. It is considered well-tolerated, with a focus on enhancing image quality while ensuring safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Veriton SPECT/CT system because it has the potential to deliver superior image quality compared to standard SPECT/CT systems. Unlike traditional gamma cameras, Veriton's advanced imaging technology could provide clearer, more detailed scans, helping doctors make more accurate diagnoses. This improvement in image quality can lead to better treatment planning and potentially improved outcomes for patients, making it a promising advancement in medical imaging.

What evidence suggests that the Veriton SPECT/CT system is effective for improving image quality?

Research has shown that the Veriton SPECT/CT system, used to evaluate participants in this trial, provides clearer images and greater sensitivity than standard gamma cameras. Studies have found that its 360° camera design enhances image quality. Specifically, research comparing the Veriton with other systems found it performed better in certain cases, such as heart imaging. This capability could enable doctors to make more accurate diagnoses. Overall, current evidence suggests that the Veriton SPECT/CT system can deliver results that match or surpass those of existing imaging systems. ^{2 5 6 7 8}

Who Is on the Research Team?

Carrie Hruska, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are already scheduled for a nuclear medicine exam. Participants must be able to lie on the Veriton imaging table for up to 40 minutes and provide informed consent. It's not open to those under 18 or anyone unable to comply with these requirements.

Inclusion Criteria

Currently scheduled to undergo a nuclear medicine exam.

Exclusion Criteria

Unwilling/unable to sign an informed consent form.

You cannot lie down on a Veriton imaging table for a maximum of 40 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Participants undergo imaging with the Veriton SPECT/CT system to assess image quality

1 year

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Veriton SPECT/CT

Trial Overview The study is testing the Veriton SPECT/CT system, a new type of gamma camera designed for nuclear medicine exams. It aims to see if it can produce better images with higher sensitivity compared to conventional cameras while maintaining or improving image quality.

How Is the Trial Designed?

Group I: Evaluation of the Veriton SPECT/CT system Experimental Treatment 1 Intervention

To determine if the Veriton system can achieve equal or better image quality than a standard SPECT/CT system.

Veriton SPECT/CT is already approved in European Union, United States for the following indications:

Approved in European Union as Veriton SPECT/CT for:

• Whole-body tomography
• Whole-body scintigraphy

Approved in United States as Veriton SPECT/CT for:

• Whole-body tomography
• Whole-body scintigraphy

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The new gamma KC-2 scintillation gamma camera offers improved spatial resolution and maximum count rate compared to the earlier KC-1 model, enhancing its diagnostic capabilities.

Real-time distortion corrections managed by a built-in microprocessor significantly increase the camera's serviceability and overall performance in medical imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Design and characteristics of a scintillation gamma camera with high spatial resolution and fast response]. Kalashnikov, SD., Krivoshein, VL., Markovskiĭ, AE., et al.[2006]

A new combined SPECT/CT system was developed using a Philips SKYLight gamma camera and a modified low-cost CT scanner, allowing for scans without moving the patient, which enhances the efficiency of imaging procedures.

In its first year, over 200 subjects were scanned, leading to improved confidence in localizing abnormalities and successful implementation of attenuation correction for various radionuclides, demonstrating the system's diagnostic effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a cost-effective modular SPECT/CT scanner. Bailey, DL., Roach, PJ., Bailey, EA., et al.[2018]

SPECT/CT systems provide enhanced localization and definition of scintigraphic findings by combining anatomical and functional imaging, leading to higher specificity and fewer indeterminate results compared to traditional imaging methods.

Clinical studies have shown that SPECT/CT is superior to planar imaging and standard SPECT in various applications, including bone scintigraphy and sentinel node detection, indicating its potential for improved diagnostic accuracy in multiple medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SPECT/CT. Buck, AK., Nekolla, S., Ziegler, S., et al.[2022]

Severe systemic reactions can occur in patients after intravenous injection of diphosphonate bone imaging agents, indicating a potential allergy to these compounds.

Skin testing can help identify reactivity to diphosphonates, and pyrophosphates may serve as a safe alternative for patients with suspected allergies to diphosphonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe systemic reaction to diphosphonate bone imaging agents: skin testing to predict allergic response and a safe alternative agent. Ramos-Gabatin, A., Orzel, JA., Maloney, TR., et al.[2016]

In a survey of 981 nuclear medicine institutions in Japan, only 15 cases of adverse reactions were reported out of 1,056,828 radiopharmaceutical administrations, resulting in a low incidence rate of 1.4 adverse reactions per 100,000 cases.

Importantly, there were no reports of deficient products, indicating a high level of safety in the use of radiopharmaceuticals during the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 38th Report on Survey of the Adverse Reaction to Radiopharmaceuticals (The 41st Survey in 2015). Matsuda, H., Uehara, T., Okazawa, H., et al.[2018]

SPECT/CT imaging combines functional data from SPECT with anatomical data from CT, enhancing the ability to distinguish between normal physiological processes and disease, which improves diagnostic accuracy.

Recent advancements in SPECT/CT technology, including high-power CT subsystems, allow for detailed anatomical assessments and better quantification of myocardial blood flow, potentially leading to improved patient outcomes in cardiac imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological development and advances in single-photon emission computed tomography/computed tomography. Seo, Y., Mari, C., Hasegawa, BH.[2022]

SPECT/CT technology has significantly advanced over the past 20 years, combining the diagnostic strengths of SPECT and the anatomical detail of CT, leading to improved sensitivity, resolution, and the ability to quantify tracer uptake accurately.

Recent innovations, including ring-shaped gantries and advanced radiopharmaceuticals, are enhancing the clinical applications of SPECT/CT, particularly in precision medicine and orthopedics, making it a mature tool ready for widespread clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SPECT/CT: Standing on the Shoulders of Giants, It Is Time to Reach for the Sky! Van den Wyngaert, T., Elvas, F., De Schepper, S., et al.[2021]

The dual-head coincidence gamma camera (Millennium VG) demonstrated an axial spatial resolution of 4.98 mm FWHM, indicating its capability for precise imaging in PET scanning.

The camera showed a consistent true high count-rate characteristic curve within the range of 0-0.2 microCi/ml, suggesting reliable performance in detecting low levels of radioactivity, although some protocol adjustments were necessary for optimal evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Performance evaluation of dual-head coincidence gamma camera for positron imaging]. Kaneta, T., Yamaguchi, K., Kurihara, H., et al.[2019]

The dual-headed gamma camera for SPECT imaging can effectively capture 511-keV photons from positron emitters, allowing for versatile imaging without the need for a dedicated PET scanner.

In a study involving 109 patients across various age groups, all FDG SPECT scans were deemed to be of acceptable quality, indicating that this method can be a cost-effective alternative for cardiac and oncologic diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology for FDG SPECT with a relatively inexpensive gamma camera. Work in progress. Drane, WE., Abbott, FD., Nicole, MW., et al.[2016]

In a review of safety data from 12 clinical studies involving 1989 patients, gadoxetate disodium showed a high safety profile, with only 10.1% of patients reporting adverse events, and only 4.1% classified as related to the drug.

The most common related adverse events were nausea and headache, each occurring in 1.1% of patients, and the safety profile remained consistent across various patient subgroups, including those with liver cirrhosis or impaired function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of gadoxetate disodium: Results from the clinical phase II-III development program and postmarketing surveillance. Endrikat, JS., Dohanish, S., Balzer, T., et al.[2022]

In a phase II clinical trial involving 104 patients, ferumoxtran-10 was found to be a safe and well-tolerated contrast agent for magnetic resonance imaging, with only 15% of patients reporting mild adverse events.

The most common side effects included dyspnea (3.8%), chest pain (2.9%), and rash (2.9%), but no serious adverse events occurred, and there were no significant changes in vital signs or laboratory results during the 48-hour observation period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: phase II clinical trial data. Sharma, R., Saini, S., Ros, PR., et al.[2019]

Over a 10-year period, the study found a low prevalence of adverse reactions to radiopharmaceuticals, with only 3.1 reports per 100,000 administrations in 2013 and 2.5 per 100,000 in 2015, indicating a generally safe profile for these substances.

The most common adverse reactions reported were rash, itching, and vomiting, with the highest number of reports associated with the radiopharmaceuticals tetrofosmin and oxidronate, suggesting that while reactions can occur, they are infrequent and typically mild.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Radiopharmaceutical Adverse Reaction Reports to the British Nuclear Medicine Society from 2007 to 2016. Kennedy-Dixon, TG., Gossell-Williams, M., Cooper, M., et al.[2018]

The VERITON CzT camera demonstrated superior sensitivity and energy resolution compared to a conventional dual-head Anger camera, with sensitivity measurements showing up to 8 times greater performance in focus mode, which could lead to more efficient imaging in clinical settings.

The CzT camera also provided high image contrast and signal-to-noise ratio even with significantly reduced acquisition times, suggesting it could enhance patient safety by allowing for lower doses of radioactive material while maintaining image quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new multipurpose whole-body CzT-based camera: comparison with a dual-head Anger camera and first clinical images. Desmonts, C., Bouthiba, MA., Enilorac, B., et al.[2020]

Citations

1. spectrum-dynamics.com spectrum-dynamics.com/products/veriton-series/

VERITON Series VERITON-CT Image Generation: A first in SPECT/CT​​ Console allows for true multi-tasking: acquisition, reconstruction, and quantitative post processing of the 3D ...

2. clinicaltrial.be clinicaltrial.be/en/details/48412?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Evaluation of the Veriton SPECT/CT System - Clinical Tria... The main purpose of this study is to evaluate a new type of gamma camera (the Veriton system) that provides a significant gain in system ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10516832/

Performance study of a 360° CZT camera for monitoring ... The objective of this study was to evaluate quantitative performance of the CZT VERITON 360° gamma camera (VERITON-CT 200 series, SW version 2.3 ...

4. mdpi.com mdpi.com/1648-9144/61/4/665

Comparative Analysis of Cardiac SPECT Myocardial ... This study aimed to compare the performance of Veriton-CT, a full-ring CZT SPECT system, with GE Discovery 530c, a dedicated cardiac fixed-angle gamma camera, ...

5. researchgate.net researchgate.net/publication/356054179_Comparing_the_patient_experience_between_a_novel_360_gamma_camera_VERITON-CT_and_a_conventional_dual_head_gamma_camera

Comparing the patient experience between a novel 360 ... Conclusion: The study provides evidence that the novel 360° gamma camera design of VERITON-CT does not lead to a significantly increased scan ...

6. trialx.com trialx.com/clinical-trials/listings/270718/evaluation-of-the-veriton-spectct-system/

Evaluation of the Veriton SPECT/CT System The main purpose of this study is to evaluate a new type of gamma camera (the Veriton system) that provides a significant gain in system ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04722185

NCT04722185 | Evaluation of the Veriton SPECT/CT System The Veriton system represents an FDA approved (510k cleared) new generation of SPECT/CT systems. It consists of 12 small gamma cameras arrayed in a circle ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/65/supplement_2/241700

Comparison of the diagnostic performances of a conventional ... Both CZT devices are more sensitive for diagnosing CAD than the Anger SPECT/CT device, with also lower radiation exposure and shortened examination times.