uEXPLORER vs Conventional PET/CT Imaging for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Claustrophobia, Significant medical condition

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal duration for a PET/CT scan to achieve the best picture quality in cancer detection. It compares a full-body scanner, called uEXPLORER, with a regular PET/CT scanner to assess whether shorter scans can still provide clear results. Individuals diagnosed with or suspected of having lung cancer, lymphoma, or melanoma, and who are scheduled for a PET/CT scan, might be suitable for this trial. Participants will undergo two scans, one on each type of scanner, to compare the results. As an unphased trial, this study allows participants to contribute to the advancement of cancer diagnostic techniques.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for cancer patients?

Research has shown that the uEXPLORER PET/CT scanner is safe for people. Studies have found that it provides detailed images of the entire body in one session, reducing the time patients spend in the scanner. This can enhance comfort and lower radiation exposure.

The regular PET/CT scanner, such as the Biograph mCT, is also widely used and considered safe. It helps doctors visualize important body functions and serves as a standard tool for diagnosing and planning cancer treatment. Both scanners are used in medical settings and have undergone thorough testing to ensure patient safety.

In summary, both the uEXPLORER and regular PET/CT scanners are well-tolerated and have been proven safe for people in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the uEXPLORER PET/CT imaging technique because it offers a groundbreaking approach to cancer detection. Unlike traditional PET/CT scans, which focus on a single region, uEXPLORER provides a total-body scan, potentially offering more comprehensive insights into cancer spread and activity. This advanced imaging could lead to earlier and more precise detection of cancer, enabling more effective treatment planning. By capturing detailed images of the entire body in a single scan, uEXPLORER promises to revolutionize how we monitor and understand cancer progression.

What evidence suggests that this trial's imaging techniques could be effective for cancer staging?

This trial will compare the uEXPLORER PET/CT scanner with conventional PET/CT imaging. Research has shown that the uEXPLORER PET/CT scanner provides high-quality images of the whole body. Studies have found it can create detailed pictures even with very low amounts of the radioactive tracer or in a short amount of time. The scanner captures images of the entire body simultaneously, unlike traditional scanners that do so piece by piece. Previous findings confirmed the scanner's ability to effectively detect multiple areas where cancer has spread. Overall, this technology offers clear and precise imaging, crucial for identifying and assessing cancers like lung cancer, lymphoma, and melanoma. ^{6 7 8 9 10}

Who Is on the Research Team?

Lorenzo Nardo, MD

Principal Investigator

UC Davis Department of Radiology

Are You a Good Fit for This Trial?

This trial is for men and women over 18 who can consent to participate, have or might have lung cancer, lymphoma, or melanoma, and need a PET/CT scan. It's not for pregnant individuals, those with claustrophobia, or anyone with a condition that could affect their safety in the study.

Inclusion Criteria

I have been referred for a PET/CT scan.

Ability to understand and willingness to sign an informed consent form.

Ability to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria

Pregnant women.

You are afraid of being in small or enclosed spaces.

Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/CT scans on both uEXPLORER and conventional PET/CT scanners to compare image quality and tumor recognition

1 day

1 imaging visit (in-person)

Follow-up

Participants are monitored for any adverse effects following the imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mCT/uEXPLORER
• uEXPLORER/mCT

Trial Overview The trial is testing if shorter scans using a new total-body PET/CT scanner (uEXPLORER) are as good as longer ones on conventional scanners for patients with lung cancer, lymphoma, or melanoma. Participants will undergo both types of scans.

How Is the Trial Designed?

Group I: uEXPLORER/mCT Experimental Treatment 1 Intervention

Each patient will undergo a scan on a total-body PET/CT scanner (uEXPLORER) and then undergo an additional scan on a conventional PET/CT scanner (mCT). The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.

Group II: mCT/uEXPLORER Experimental Treatment 1 Intervention

Each patient will undergo a scan on a conventional PET/CT scanner (mCT) and then undergo an additional scan on a total-body PET/CT scanner (uEXPLORER) . The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

Imaging plays a crucial role in improving survival outcomes in cancer care, as evidenced by its effectiveness in various scenarios such as breast cancer screening and staging of non-small cell lung cancer.

Modeling studies suggest that the most significant survival benefits from imaging may be found in mildly symptomatic patients, while even modest improvements in survival can lead to reduced healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can imaging help improve the survival of cancer patients? Miles, K.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8729871/

Performance Evaluation of the uEXPLORER Total-Body ... The uEXPLORER PET/CT scanner has an axial field-of-view (AFOV) of 194.0 cm, allowing PET data collection from the entire human body simultaneously and greatly ...

2. ejnmmiphys.springeropen.com ejnmmiphys.springeropen.com/articles/10.1186/s40658-023-00573-4

A proper protocol for routine 18F-FDG uEXPLORER total-body ... Our study demonstrates the excellent imaging performance of uEXPLORER PET/CT for total-body imaging, which can be acquired with high quality ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11014840/

Performance and application of the total-body PET/CT ... The total-body PET/CT system enables high-resolution whole-body imaging, even under extreme conditions such as ultra-low dose, extremely fast imaging speed.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0001299824000503

Total Body PET-CT Protocols in Oncology The aim of this review is to present dedicated PET acquisition protocols for oncological studies with LAFOV scanners, including static and dynamic acquisition ...

5. ascopost.com ascopost.com/news/july-2020/first-results-of-total-body-dynamic-pet-scan/

First Results of Total-Body Dynamic PET Scan Multiple metastases were identified on the dynamic PET/CT scan, confirming that it is feasible to perform total-body kinetic modeling and ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559089/

PET Scanning - StatPearls - NCBI Bookshelf - NIH PET scanning is an imaging technique widely used in oncology. This technique uses radiotracers to measure various metabolic processes in the body.

7. radiologyinfo.org radiologyinfo.org/en/info/pet

PET/CT - Positron Emission Tomography/Computed ... A PET scan measures important body functions, such as metabolism. It helps doctors evaluate how well organs and tissues are functioning.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10184051/

A Review of PET Imaging Tracers and Methods ... PET/CT data can be incorporated into radiation treatment planning through cognitive fusion, rigid registration, deformable registration, or PET/CT simulation ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2352047722000624

Common PET/CT radiopharmaceuticals and applications This review provides mechanism and clinical indication, as well as limitations and pitfalls of various PET tracers commonly used in cancer imaging.

10. siemens-healthineers.com siemens-healthineers.com/en-us/molecular-imaging/pet-ct/biograph-mct

Biograph mCT PET/CT scanner Biograph mCT PET/CT nuclear medicine scanner. A truly hybrid system that supports your ability to serve more patients and generate more revenue.