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

Not currently recruiting at 1 trial location

Overseen By Yuan-Chuan Tai, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Poorly controlled diabetes, Obesity, others

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 tests a new PET/CT imaging technique called AWSM-PET (Augmented Whole-body Scanning via Magnifying PET) to determine if it detects cancer more effectively than standard PET/CT. The researchers aim to assess whether AWSM-PET provides clearer images, particularly for small cancerous lesions. This trial is open to adults diagnosed with or suspected of having cancer who are already scheduled for a standard PET/CT scan. Participants should be willing to undergo additional imaging and tolerate up to 30 minutes of scanning. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in cancer detection technology.

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 prior data suggests that the AWSM-PET technique is safe for cancer detection?

Research has shown that AWSM-PET technology enhances PET scans' ability to detect cancer by improving sensitivity and clarity. Computer-based tests, known as Monte Carlo simulations, demonstrated a 36% to 42% improvement in the AWSM-PET device's signal detection. However, specific safety information about the AWSM-PET technology itself is not available.

The 18F-fluorodeoxyglucose used in PET scans is a widely used and FDA-approved agent for cancer detection. It is generally safe for patients, with most side effects being mild, such as slight pain or discomfort at the injection site. Serious side effects are rare.

In summary, while specific safety data for the AWSM-PET device is lacking, components like 18F-fluorodeoxyglucose are commonly used and considered safe in medical practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AWSM-PET technique because it promises to enhance cancer detection compared to the standard PET/CT scans. Unlike traditional methods, AWSM-PET uses a magnifying technique that could provide more detailed images, potentially leading to earlier and more accurate diagnoses. This approach might improve the detection of smaller tumors that standard scans could miss, offering hope for better outcomes in cancer treatment.

What evidence suggests that the AWSM-PET technique is effective for cancer detection?

This trial will compare Augmented Whole-body Scanning via Magnifying PET (AWSM-PET) with standard PET/CT for cancer detection. Research has shown that AWSM-PET technology can enhance cancer detection. Studies indicate that this scanner is 36% to 42% more sensitive, effectively identifying smaller cancer spots. The technology's accuracy is high, with a score of 0.962 out of 1, indicating strong reliability. AWSM-PET provides clearer and more detailed images than standard PET scans, facilitating the identification of even tiny cancer lesions. This suggests AWSM-PET could be a valuable tool for more accurate cancer detection than current methods. ^{1 2 5 6 7}

Who Is on the Research Team?

Yuan-Chuan Tai, Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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

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

I am not pregnant or have been amenorrheic for at least 12 months.

Exclusion Criteria

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 18F- fluorodeoxyglucose
• Augmented Whole-body Scanning via Magnifying PET
• FDG-PET/CT

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as 18F-FDG for:

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

Approved in United States as 18F-FDG for:

• Cancer staging
• Re-staging
• Monitoring response to therapy for various cancers
• Detection of prostate and neuroendocrine cancers

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

In a study of 104 patients with breast cancer, whole body positron emission tomography (FDG-PET) demonstrated superior sensitivity compared to traditional imaging methods like sonography, CT, and MRT.

FDG-PET allows for earlier detection of lymph node metastasis by identifying functional metabolic changes, making it a valuable tool for both initial assessment and follow-up in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PET scan in general practice for diagnosis of breast carcinoma]. Ruhlmann, J., Oehr, P., Bender, H., et al.[2016]

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]

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]

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]

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]

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]

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]

Dynamic whole-body (D-WB) FDG PET/CT scanning is feasible in clinical settings and produces high-quality images that enhance lesion contrast compared to standard static SUV images.

While MRFDG imaging did not identify more malignant lesions, it reduced false positives and provided better quantification, suggesting it may be particularly useful for specific patient groups or in evaluating treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dias, AH., Pedersen, MF., Danielsen, H., et al.[2021]

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 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, 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7673659/

Augmented Whole-body Scanning via Magnifying PET - PMC Monte Carlo simulation shows 36%−42% improvement in system sensitivity by a dual-panel AWSM-PET device. The area under the ROC curve is 0.962 by a native ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05513027

Augmented Whole-body Scanning Via Magnifying PET/CT ... This study will evaluate preliminarily whether the AWSM-PET/CT technology can provide additional high-resolution PET/CT images displayed concurrently with the ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/supplement_2/242490

Initial Results of an AWSM-PET Device for Augmented Whole ... These add-on detectors capture extra high-resolution PET data concurrently during a whole-body (WB) scan (Fig. 1c). The primary objective of ...

4. ui.adsabs.harvard.edu ui.adsabs.harvard.edu/abs/2020ITMI...39.3268J/abstract

Augmented Whole-Body Scanning via Magnifying PET - ADS Monte Carlo simulation shows 36%–42% improvement in system sensitivity by a dual-panel AWSM-PET device. The area under the ROC curve is 0.962 by a native ...

5. snmmi.org snmmi.org/Web/Web/News/Articles/New-Whole-Body-PET-Technology-Offers-Cost-Effective-Solution-to-Improve-Image-Resolution-and-Sensiti.aspx

New Whole-Body PET Technology Offers Cost-Effective ... “The additional high-resolution data from the AWSM-PET device can enhance the overall image resolution and reduce statistical noise,” noted Tai.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31899415/

Augmented Whole-Body Scanning via Magnifying PET A novel technique, called augmented whole-body scanning via magnifying PET (AWSM-PET), that improves the sensitivity and lesion detectability of a PET scanner ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05513027?tab=results

Augmented Whole-body Scanning Via Magnifying PET/CT ... Augmented Whole-body Scanning Via Magnifying PET/​CT (AWSM-PET/​CT) Techniques Abilities to Improve Upon the Diagnostic Accuracy of the ...