PennPET Explorer Scanner Evaluation for Body Imaging

Overseen By Austin Pantel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Serious medical conditions, others

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

Compensation: Varies

Number of Visits: 1

99 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team to get a clear answer.

What data supports the effectiveness of the treatment Long AFOV PennPET Explorer, PennPET Explorer Scanner, Long AFOV PennPET Explorer?

The PennPET Explorer scanner, with its long axial field of view, has shown to provide high-quality images with less radiation exposure and shorter scan times compared to conventional scanners. It has demonstrated the ability to effectively image major body organs simultaneously and track biological processes over time, offering potential advantages in diagnosing and monitoring diseases. ^{1 2 3 4 5}

Is the PennPET Explorer Scanner safe for human use?

The safety of radiopharmaceuticals, which are used in imaging like the PennPET Explorer Scanner, shows a very low incidence of adverse reactions, with only 1.4 cases per 100,000 administrations reported in a large survey. This suggests that such imaging procedures are generally safe for humans. ^{6 7 8 9 10}

How does the PennPET Explorer treatment differ from other imaging treatments?

The PennPET Explorer is unique because it can image the entire body at once with higher sensitivity than traditional scanners, allowing for shorter scan times or lower doses of radioactive tracers without losing image quality. This makes it particularly effective for tracking biological processes over time and provides detailed images with less radiation exposure. ^{1 2 4 11 12}

What is the purpose of this trial?

Positron Emission Tomography (PET) is a procedure that uses a special type of machine to take pictures of the inside of the body after a radioactive drug is administered. The radioactive drug that is used for this study may be an FDA approved imaging drug or may be used as an investigational imaging drug as part of another study for which participants are taking part. PET using various radiotracers is useful for the diagnosis of various diseases, including cancer, brain diseases, infection, and heart or lung disease. The purpose of this study is to test a research PET machine called the PennPET Explorer long-axial field-of-view scanner. This research PET machine can image a larger section of the body than the current clinical PET scanners, allowing most of the body to be imaged at one time. This scanner is still an investigational device and is being tested in this study to collect more information about how best to use this type of whole body scanner.

Eligibility Criteria

This trial is for adults over 18 who can consent to participate or have a representative to do so. It's suitable for those with cognitive impairment and healthy subjects interested in PET imaging research. People with serious health issues, psychological conditions, or mobility problems that could affect their safety or participation are not eligible.

Inclusion Criteria

You or your study partner must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Participants or study partner must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. Subjects who are unable to provide consent must have a legally authorized representative or designated 'study partner' who can provide consent on their behalf.

Exclusion Criteria

Serious or unstable medical or psychological conditions or lack of mobility that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study

Inability to tolerate imaging procedure in the opinion of an investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo PET imaging using the PennPET Explorer with a radioactive imaging drug

1 day per imaging session

1 visit (in-person) per imaging session

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• Long AFOV PennPET Explorer

Trial Overview The study is evaluating the PennPET Explorer Scanner, which is an investigational PET machine capable of imaging larger sections of the body at once compared to current clinical scanners. The goal is to gather data on how best to utilize this whole-body scanner.

Participant Groups

Group I: PennPET Explorer Experimental Treatment 1 Intervention

All subjects will be scanned in the CT scanner and then the scanner bed will be moved into position in the PennPET Explorer for initiation of the PET scan. For all PET scans a radioactive imaging drug is used. The radiotracer injection may be performed according to one of the following scenarios: 1. As part of a clinical standard-of-care (SOC) PET/CT or PET/MRI scan (using an FDA-approved radiotracer; the PennPET Explorer cannot yet accommodate a study that requires a commercially available 510(k)-approved instrument for clinical results, subjects in this group will be scanned on both a commercial instrument (PET/CT or PET.MRI) and the PennPET Explorer), 2. As part of another research study (using either an FDA-approved radiotracer or an investigational radiotracer), 3. As a research injection designed specifically to utilize the PennPET Explorer (using an FDA-approved radiotracer).

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

The PennPET Explorer, a new whole-body imaging device, allows for high-sensitivity imaging of major organs, enabling shorter scan times or reduced radioactive tracer doses without sacrificing image quality, as demonstrated in initial studies with healthy and clinical subjects.

In clinical applications, the PennPET Explorer provided better delineation of disease extent compared to traditional methods and achieved comparable diagnostic quality with significantly lower radiation exposure, showcasing its potential for safer and more effective imaging in medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PennPET Explorer: Human Imaging on a Whole-Body Imager. Pantel, AR., Viswanath, V., Daube-Witherspoon, ME., et al.[2022]

The PennPET Explorer, a new prototype for total-body positron emission tomography (PET) imaging, has successfully expanded its axial field of view to 1.12 meters, enhancing its imaging capabilities.

Initial performance tests and human imaging studies have shown promising results, indicating that the PennPET Explorer could significantly improve the effectiveness of PET imaging in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the PennPET Explorer: A Whole-body Imager with Scalable Axial Field-of-View. Pantel, AR., Viswanath, V., Karp, JS.[2021]

Long axial field of view (AFOV) PET/CT scanners provide significant advantages over conventional scanners, including higher image quality, faster whole-body scans, and reduced radiation exposure for patients due to their improved geometric efficiency.

The implementation of Long AFOV PET/CT technology necessitates careful consideration of facility design and workflows to maximize benefits while managing radiation exposure for both patients and staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential advantages and workflow challenges of long axial field of view PET/CT. Chen, WJ., Rae, WID., Kench, PL., et al.[2023]

The PennPET Explorer is a new whole-body imaging system that features a long axial field of view and high sensitivity, achieving 55 kcps/MBq, which enhances its ability to detect and visualize lesions in the body.

Initial tests on healthy volunteers confirmed the system's high spatial resolution of 4.0 mm and excellent timing resolution of 256 ps, validating its design for accurate and effective imaging in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PennPET Explorer: Design and Preliminary Performance of a Whole-Body Imager. Karp, JS., Viswanath, V., Geagan, MJ., et al.[2022]

The uEXPLORER PET scanner, designed to overcome the limitations of conventional PET scanners, demonstrated a high level of sensitivity and accuracy in simulations, validating its potential for improved imaging in clinical settings.

Monte Carlo simulations showed that optimizing the time coincidence window can enhance the scanner's performance by reducing random coincidences, which is crucial for improving image quality and diagnostic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accurate modeling and performance evaluation of a total-body pet scanner using Monte Carlo simulations. Rezaei, H., Sheikhzadeh, P., Ghafarian, P., et al.[2023]

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]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

In a review of 24 Phase I studies involving 430 healthy male volunteers over 5 years, the overall incidence of adverse events was 13.5%, with a higher rate for active drug treatments (15.3%) compared to placebo (7.4%).

Severe adverse events occurred in 20 cases (0.36%), but there were no deaths or life-threatening incidents, indicating that while adverse events are common, they are generally not severe in Phase I trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. Sibille, M., Deigat, N., Olagnier, V., et al.[2019]

In a study of 4,832 outpatients undergoing contrast-enhanced MRI, the use of a patient-friendly audiovisual (AV) system significantly reduced the rate of adverse reactions to gadolinium-based contrast agents from 1.6% in the control group to 0.7% in the AV group.

While the AV system decreased the occurrence of adverse reactions, it did not affect the severity of these reactions, indicating that the AV system is effective in improving patient experience without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Patient-Friendly Audiovisual Systems and MRI Contrast Agent to Adverse Reactions. Nitta, K., Matsumoto, K., Yokota, H., et al.[2023]

Gadopentetate dimeglumine (Gd-DTPA) has been safely used in over 45 million MRI procedures since its introduction in 1988, with adverse events (AEs) reported in less than 0.01% of cases, indicating a strong safety profile.

The analysis revealed that while serious AEs accounted for only 9.3% of reports, there were significant regional differences in AE reporting, with the U.S. reporting nearly double the AEs compared to Europe, highlighting the importance of ongoing pharmacovigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Knopp, MV., Balzer, T., Esser, M., et al.[2015]

The updated PennPET Explorer total-body PET scanner achieved a significant increase in sensitivity (1.8 times) and count-rate performance, demonstrating its enhanced capability for imaging compared to previous models with axial gaps.

The scanner's performance evaluation indicates improved axial spatial resolution and consistent image quality across its 142 cm field of view, suggesting it could set new standards for total-body PET imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance evaluation of the PennPET explorer with expanded axial coverage. Dai, B., Daube-Witherspoon, ME., McDonald, S., et al.[2023]

Long axial field-of-view (LAFOV) PET-CT instruments significantly enhance imaging sensitivity and allow for simultaneous imaging of the entire body or major organs without needing to move the patient, which improves the measurement of kinetics across multiple organs.

Initial human studies with the uEXPLORER and PennPET EXPLORER systems have shown successful implementation of LAFOV technology, highlighting its potential benefits for both clinical and research applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total Body PET: Why, How, What for? Surti, S., Pantel, AR., Karp, JS.[2021]

References

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

PennPET Explorer: Human Imaging on a Whole-Body Imager. [2022]

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

Update on the PennPET Explorer: A Whole-body Imager with Scalable Axial Field-of-View. [2021]

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

The potential advantages and workflow challenges of long axial field of view PET/CT. [2023]

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

PennPET Explorer: Design and Preliminary Performance of a Whole-Body Imager. [2022]

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

Accurate modeling and performance evaluation of a total-body pet scanner using Monte Carlo simulations. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

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

7. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. [2019]

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

Relationship Between Patient-Friendly Audiovisual Systems and MRI Contrast Agent to Adverse Reactions. [2023]

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

Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Performance evaluation of the PennPET explorer with expanded axial coverage. [2023]

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

Total Body PET: Why, How, What for? [2021]