AWSM-PET Technique vs Standard PET/CT for Cancer Detection

Recruiting in Palo Alto (17 mi)

Overseen by Yuan-Chuan Tai, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Washington University School of Medicine

Disqualifiers: Poorly controlled diabetes, Obesity, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) has been demonstrated to outperform other imaging modalities such as CT and magnetic resonance imaging (MRI) for the detection of metastatic cancers. Therefore, it is currently used for cancer staging, re-staging, and for monitoring response to therapy for many types of cancers. Major advances in PET imaging came to the field in 2016, 2020, 2021 and 2023 when the FDA approved additional PET imaging agents to expand the role of cancer detection to include prostate and neuroendocrine cancers. Despite its wide use and success, the diagnostic accuracy of PET/CT is suboptimal for lesions that are significantly smaller than 1 cm due primarily to limitations on image resolution and system sensitivity. The investigators have developed an Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) technology that can improve the image resolution and system sensitivity of current and future PET/CT scanners. This study will evaluate preliminarily whether the AWSM-PET/CT technology can provide additional high-resolution PET/CT images displayed concurrently with the standard of care PET/CT images to improve overall accuracy in depicting malignant lesions in cancer patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the AWSM-PET/CT treatment for cancer detection?

Research shows that combining PET with CT imaging improves cancer diagnosis and treatment planning by providing both functional and anatomical information, which helps in better identifying and monitoring tumors. Studies have found that PET/CT is more effective than traditional imaging methods in detecting cancer and guiding treatment decisions. ^{1 2 3 4 5}

Is the AWSM-PET/CT technique generally safe for humans?

The AWSM-PET/CT technique, which involves 18F-FDG PET/CT scans, is generally considered safe, but it does expose patients to radiation. Studies show that the CT component contributes significantly to the radiation dose, and efforts are made to minimize this exposure, especially in sensitive groups like children and obese patients. ^{6 7 8 9 10}

How does the AWSM-PET Technique differ from standard PET/CT for cancer detection?

The AWSM-PET Technique, which uses 18F-fluorodeoxyglucose (FDG), offers enhanced whole-body imaging by combining functional and structural data in one scan, allowing for earlier detection of cancerous changes compared to standard imaging methods. This approach improves sensitivity and provides detailed anatomical and metabolic information, making it more effective for diagnosing and monitoring cancer. ^{5 11 12 13 14}

Research Team

Yuan-Chuan Tai, Ph.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 18 with suspected or confirmed carcinoma who need a PET/CT scan. They must understand and consent to the study, possibly undergo biopsy or surgery before other treatments, and be able to lie still for about 30 minutes during imaging. Women of childbearing age need a negative pregnancy test.

Inclusion Criteria

I am 18 years old or older.

Patients must be able to understand and sign an IRB-approved informed consent form that allows access to prior medical records, participation in the study and chart review follow up

Willing to undergo FDG-PET/CT imaging with AWSM-PET

Exclusion Criteria

My fasting blood sugar level is not above 200 mg/dL.

Patients whose weight is over 250 lbs or whose body habitus prohibits the AWSM-PET insert device from being placed at the end of the imaging field of view

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging and Scanning

Participants undergo SOC PET/CT scan with AWSM PET device for approximately 2 ½ - 3 hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

45 days

Extended Follow-up

Further monitoring and correlation with histopathologic results for up to 9 months

9 months

Treatment Details

Interventions

• 18F- fluorodeoxyglucose (Radiopharmaceutical)
• Augmented Whole-body Scanning via Magnifying PET (Imaging)
• FDG-PET/CT (Imaging)

Trial Overview The AWSM-PET technique's ability to detect malignant lesions in cancer patients is being compared against the standard FDG PET/CT scans. The goal is to see if AWSM-PET can provide better image resolution and sensitivity, especially for very small lesions.

Participant Groups

Group I: Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) Experimental Treatment 2 Interventions

All enrolled subjects will undergo SOC PET/CT scan with an AWSM PET device positioned at the far end of the Biograph Vision PET/CT scanner. The patient will receive injection of the PET radiopharmaceutical according to the SOC PET/CT protocol dosing schedule. The entire study will require approximately 2 ½ - 3 hours (from the time patient arrives to the completion of the scan).

18F- fluorodeoxyglucose is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as 18F-FDG for:

• Cancer staging
• Re-staging
• Monitoring response to therapy for various cancers

Approved in Japan as 18F-FDG for:

• Cancer staging
• Re-staging
• Monitoring response to therapy for various cancers

Approved in China as 18F-FDG for:

• Cancer staging
• Re-staging
• Monitoring response to therapy for various cancers

Approved in Switzerland as 18F-FDG for:

• Cancer staging
• Re-staging
• Monitoring response to therapy for various cancers

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

In a study of 150 patients with colorectal liver metastases, adding (18)F-FDG PET to conventional CT imaging significantly reduced the rate of futile laparotomies from 45% to 28%, indicating improved patient selection for surgery.

The findings suggest that incorporating (18)F-FDG PET into the staging process can prevent unnecessary surgeries in approximately 1 out of every 6 patients, enhancing clinical management and potentially improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved selection of patients for hepatic surgery of colorectal liver metastases with (18)F-FDG PET: a randomized study. Ruers, TJ., Wiering, B., van der Sijp, JR., et al.[2016]

PET-CT imaging significantly enhances the diagnosis, staging, and monitoring of cancer treatment, providing a powerful combination of functional and anatomical information.

The use of integrated PET-CT improves the characterization of unclear lesions and reduces variability in interpretations, which can directly influence treatment planning and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated PET-CT: evidence-based review of oncology indications. Sachelarie, I., Kerr, K., Ghesani, M., et al.[2016]

Recent advancements in technology have made whole-body FDG-PET/MRI a promising imaging technique for lower gastrointestinal malignancies, offering better soft tissue contrast and molecular imaging capabilities compared to traditional PET/CT.

FDG-PET/MRI can play a crucial role in the initial diagnosis, treatment response assessment, and evaluation of metastatic disease in colorectal and anal cancers, potentially improving patient management in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/MRI in colorectal and anal cancers: an update. Jayaprakasam, VS., Ince, S., Suman, G., et al.[2023]

Whole-body PET imaging using [F-18]FDG is effective for cancer management, with a sensitivity of over 85%, but it often struggles with specificity due to normal physiological FDG accumulation in various organs.

Combining PET with CT imaging in a single session enhances the accuracy of tumor localization by allowing better differentiation between normal and abnormal FDG uptake, which can significantly improve patient management in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

20. The Case for PET/CT. Experience at the University of Pittsburgh. Kluetz, P., Villemagne, V., Meltzer, C., et al.[2020]

The study assessed the effective radiation dose from 18F-FDG PET/CT scans in 156 patients, finding an average dose of 3.88 mSv for females and 3.71 mSv for males, which is lower than previous studies.

The results suggest that while the radiation exposure from PET/CT scans is relatively low, the risk-benefit ratio of the procedure should be carefully considered, especially given the high radiation doses associated with CT imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiobiological risks in terms of effective dose and organ dose from 18F-FDG whole-body PET/CT procedures. Alameen, S., Tamam, N., Awadain, S., et al.[2022]

In a study involving 204 adult patients, the whole-body effective doses from PET/CT scans using 18F-FDG were found to be 20.54 mSv for all patients, with the CT component contributing significantly to this dose (66% overall).

The findings highlight the need to improve CT protocols to minimize radiation exposure, particularly for obese patients, as the CT component is the primary contributor to the effective dose in PET/CT scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ESTIMATION OF PATIENT ORGAN AND WHOLE-BODY DOSES IN [18F-FDG] PET/CT SCAN. Kessara, A., Buyukcizmeci, N., Gedik, GK.[2023]

In a study of 100 children with tumors undergoing 18F-FDG PET/CT imaging, optimal protocols were identified that reduced radiation exposure while maintaining image quality, specifically group H for CT (80 kV/40-59 mA/14) and group g for PET (0.08 mCi/kg/180 s).

The research demonstrated that while several imaging groups achieved good quality images, the differences in image quality among these groups were not statistically significant, indicating that multiple settings can be effective for pediatric imaging without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized low-dose positron emission tomography/computed tomography schemes in pediatric tumor patients: a randomized clinical trial. Yu, S., Qian, Z., Liu, H., et al.[2022]

In a study of 483 patients, the mean effective radiation dose from low-dose whole-body PET/CT scans was approximately 14.5 mSv, which is a significant consideration for patient safety during imaging procedures.

The research suggests that further reductions in radiation exposure could be achieved through advanced techniques like iterative CT reconstruction and optimized low-dose FDG protocols, potentially lowering doses to below 10 mSv.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective evaluation of radiation dose associated with low dose FDG protocols in whole-body PET/CT. Willowson, KP., Bailey, EA., Bailey, DL.[2016]

Integrated PET/CT imaging combines the sensitivity of PET for detecting tumor metabolic activity with the anatomical detail provided by CT, allowing for efficient whole-body staging and functional assessment of cancers in under 20 minutes.

Using (18)F-labelled fluoro-deoxy-D-glucose (FDG), which accumulates in cancer cells due to their high glycolytic activity, PET/CT has proven highly effective in diagnosing and staging various cancers, including colorectal, lung, and breast cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT for the staging and follow-up of patients with malignancies. Poeppel, TD., Krause, BJ., Heusner, TA., et al.[2022]

PET/CT imaging using the glucose analogue FDG is becoming the leading diagnostic tool in oncology, with over 2000 scanners in use globally, providing crucial information for diagnosing, staging, and monitoring cancer.

Studies show that combining PET with CT imaging offers significant diagnostic advantages over using either method alone, particularly in various cancers such as sarcoma, lung cancer, and breast cancer, ultimately impacting patient management positively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT imaging: The incremental value of assessing the glucose metabolic phenotype and the structure of cancers in a single examination. Czernin, J., Benz, MR., Allen-Auerbach, MS.[2016]

PET-CT imaging, which combines functional and structural imaging, significantly enhances the accuracy of diagnosing and monitoring various cancers by measuring the uptake of F-18 FDG, a glucose analogue, in tumor cells.

F-18 FDG PET-CT is particularly effective for initial cancer staging, detecting recurrence, and assessing treatment response across multiple cancer types, including lung, colorectal, and breast cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of positron emission tomography-computed tomography in oncology. Kumar, R., Halanaik, D., Malhotra, A.[2021]

Positron emission tomography (PET) using fluorine 18 fluorodeoxyglucose (FDG) is a valuable tool for diagnosing and staging cancer, as it provides functional imaging that complements traditional anatomical imaging techniques like computed tomography (CT).

The introduction of combined PET/CT scanners allows for simultaneous acquisition of anatomical and functional images, improving the accuracy of cancer diagnosis and treatment monitoring, with over 800 such scanners currently in use worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT: form and function. Blodgett, TM., Meltzer, CC., Townsend, DW.[2022]

References

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

Improved selection of patients for hepatic surgery of colorectal liver metastases with (18)F-FDG PET: a randomized study. [2016]

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

Integrated PET-CT: evidence-based review of oncology indications. [2016]

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

PET/MRI in colorectal and anal cancers: an update. [2023]

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

20. The Case for PET/CT. Experience at the University of Pittsburgh. [2020]

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[PET scan in general practice for diagnosis of breast carcinoma]. [2016]

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Radiobiological risks in terms of effective dose and organ dose from 18F-FDG whole-body PET/CT procedures. [2022]

7. England pubmed.ncbi.nlm.nih.gov

ESTIMATION OF PATIENT ORGAN AND WHOLE-BODY DOSES IN [18F-FDG] PET/CT SCAN. [2023]

8. China pubmed.ncbi.nlm.nih.gov

Optimized low-dose positron emission tomography/computed tomography schemes in pediatric tumor patients: a randomized clinical trial. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A retrospective evaluation of radiation dose associated with low dose FDG protocols in whole-body PET/CT. [2016]

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Clinical feasibility and impact of fully automated multiparametric PET imaging using direct Patlak reconstruction: evaluation of 103 dynamic whole-body 18F-FDG PET/CT scans. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

PET/CT for the staging and follow-up of patients with malignancies. [2022]

12. Ireland pubmed.ncbi.nlm.nih.gov

PET/CT imaging: The incremental value of assessing the glucose metabolic phenotype and the structure of cancers in a single examination. [2016]

13. India pubmed.ncbi.nlm.nih.gov

Clinical applications of positron emission tomography-computed tomography in oncology. [2021]

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

PET/CT: form and function. [2022]