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

Trial Summary

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 data supports the effectiveness of the treatment Veriton SPECT/CT?

The Veriton SPECT/CT system combines two imaging techniques, SPECT and CT, to provide both functional and anatomical information, which helps in better localization and definition of findings. Studies have shown that SPECT/CT is superior to other imaging methods in certain applications, such as bone and parathyroid imaging, and it improves the detection of sentinel nodes, which can be crucial for accurate diagnosis and treatment planning. ^{1 2 3 4 5}

Is the Veriton SPECT/CT safe for use in humans?

The available research does not provide specific safety data for Veriton SPECT/CT or its related names. However, general data on radiopharmaceuticals, which are often used in imaging like SPECT/CT, show a low incidence of adverse reactions, suggesting they are generally safe for use in humans. ^{6 7 8 9 10}

How is the Veriton SPECT/CT treatment different from other treatments?

The Veriton SPECT/CT is unique because it combines SPECT (a type of imaging that shows how blood flows to tissues and organs) and CT (a detailed X-ray) in one machine, allowing patients to be scanned without moving between devices. This setup improves diagnostic accuracy and is more cost-effective and adaptable compared to traditional dual-head gamma cameras. ^{1 4 11 12 13}

What is the purpose of this trial?

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 sensitivity and improved image quality compared to a conventional gamma camera that can achieve equal or better image quality than a standard SPECT/CT system.

Research Team

Carrie Hruska, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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 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]

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]

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 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]

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]

References

1. Germany 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Technological development and advances in single-photon emission computed tomography/computed tomography. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

SPECT/CT. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Development of a cost-effective modular SPECT/CT scanner. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

SPECT/CT: Standing on the Shoulders of Giants, It Is Time to Reach for the Sky! [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of gadoxetate disodium: Results from the clinical phase II-III development program and postmarketing surveillance. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Severe systemic reaction to diphosphonate bone imaging agents: skin testing to predict allergic response and a safe alternative agent. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: phase II clinical trial data. [2019]

9. Japan pubmed.ncbi.nlm.nih.gov

The 38th Report on Survey of the Adverse Reaction to Radiopharmaceuticals (The 41st Survey in 2015). [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Radiopharmaceutical Adverse Reaction Reports to the British Nuclear Medicine Society from 2007 to 2016. [2018]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Design and characteristics of a scintillation gamma camera with high spatial resolution and fast response]. [2006]

12. Japan pubmed.ncbi.nlm.nih.gov

[Performance evaluation of dual-head coincidence gamma camera for positron imaging]. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Technology for FDG SPECT with a relatively inexpensive gamma camera. Work in progress. [2016]