Breast-Dedicated PET Camera for Breast Cancer

Overseen By Risa Jiron

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Disqualifiers: Allergies to FDG, Pregnant, 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 type of PET camera designed specifically for breast cancer. The goal is to evaluate its effectiveness in a clinical setting and identify any practical challenges. The trial uses a harmless tracer called 18F-FDG (Fluorodeoxyglucose F 18) to highlight cancer cells during the scan. Suitable participants have breast cancer that is at least 5 mm in size and have undergone recent imaging tests like an MRI or CT scan. As an Early Phase 1 trial, this research aims to understand how the new PET camera functions in people, offering participants a chance to contribute to pioneering advancements in breast cancer imaging.

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 study team or your doctor.

What prior data suggests that this breast-dedicated PET camera is safe for use in breast cancer detection?

Research has shown that FDG-PET imaging is a common tool for diagnosing many types of cancer, using a special substance called 18F-FDG to identify cancer cells. Studies have found this substance to be generally safe for patients. Although concerns about radiation exposure exist, they are common with many imaging tests.

One study found that using 18F-FDG in PET scans accurately detected the spread of cancer in patients, demonstrating its effectiveness and safety for imaging. The new breast-dedicated PET camera aims to help doctors see breast cancer more clearly, using the same 18F-FDG substance.

As this is an early-phase trial, it primarily tests the camera's safety and effectiveness in a clinical setting. Early-phase trials typically focus on safety and closely monitor any side effects. So far, existing data suggest that using 18F-FDG in imaging is relatively safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the breast-dedicated PET camera because it offers a more focused imaging approach for detecting breast cancer than standard PET scans. Unlike traditional imaging techniques, this camera is specifically designed for breast tissue, potentially providing clearer and more detailed images. By using the standard 18F-FDG tracer with a specialized PET camera, the hope is to improve early detection accuracy and help tailor more effective treatment plans for patients. This could lead to earlier intervention and better outcomes for those with breast cancer.

What evidence suggests that this breast-dedicated PET camera is effective for breast cancer?

Research shows that the breast-dedicated PET camera, which participants in this trial will experience, holds promise for detecting breast cancer. Studies indicate it surpasses traditional methods in spotting early breast cancer, allowing detection when the cancer is still small. For example, it has a 95% success rate in detecting breast lumps, which is very high. This camera uses a standard tracer called 18F-FDG to highlight cancerous tissues. Early results suggest it might also excel at identifying aggressive tumors due to its precise imaging. Overall, this new technology could enhance breast cancer detection and diagnosis. ^{6 7 8 9 10}

Who Is on the Research Team?

Wendy B DeMartini

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with biopsy-confirmed breast cancer that's at least 5 mm in size, as seen on mammogram or ultrasound. They must have had a recent imaging test within the last 60 days and be able to give informed consent. It's not open to those allergic to FDG, pregnant or nursing women, or anyone with conditions that could affect their participation.

Inclusion Criteria

My breast cancer is confirmed by biopsy and measures 5 mm or larger.

Prior diagnostic imaging test(s) with another modality such as MRI, CT, or x-ray mammography (or other applicable imaging modalities) within 60 days prior to the study date.

Documented written informed consent document.

Exclusion Criteria

Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.

Pregnant or nursing.

Known allergies to FDG

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo imaging using the breast-dedicated PET camera with standard PET 18-F FDG tracer dose

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-FDG
• Breast-dedicated PET camera

Trial Overview The study is testing a new 'breast-dedicated' PET camera designed for high-resolution images of breast tissue using an imaging agent called 18F-FDG. The aim is to understand how well this technology works in a clinical setting and what practical issues might arise.

How Is the Trial Designed?

Group I: 18-F FDG Study using Breast-Dedicated PET Camera Experimental Treatment 2 Interventions

Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5903937/

A dedicated breast‐PET/CT scanner: Evaluation of basic ... The basic performance characteristics of a new dedicated breast‐PET/CT scanner are good, demonstrating that its performance is similar to current dedicated PET ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9587931/

Diagnostic performance of dedicated breast positron ... The sensitivity of dbPET for early breast cancer was higher than that of WBPET/MRI. High SUVmax was related to aggressive features of tumours.

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rycan.230020

Breast Cancer Detection Using a Low-Dose PEM System This study demonstrates the feasibility of an organ-targeted PET system that allows the detection of invasive breast cancer using low doses of fluorine 18– ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X17301006

Higher breast cancer conspicuity on dbPET compared to ... Patient/breast/lesion-based sensitivities were 95%, 95%, and 92%, respectively, for dbPET, and 95%, 94%, and 88%, respectively, for WB-PET/CT. Mean ± standard ...

5. nature.com nature.com/articles/s41598-020-78865-3

Evaluation of primary breast cancers using dedicated ... In this study, we assessed [18F]FDG uptake in pre-treatment breast cancer patients that received both dbPET and wbPET to characterize the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12240139/

The safety and clinical impact of ultra-low-dose FDG-PET ... FDG-PET imaging is a standard diagnostic tool for many cancers. However, its use in PABC staging is controversial due to potential radiation risks to the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8458550/

Benefits and harms of implementing [18F]FDG-PET/CT for ... [18F]FDG-PET/CT reported breast cancer metastases in 72 of 225 women (32.0%), and metastases were verified by biopsy in 52 (52/225, 23.1%). Prior probability ...

8. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.241850

The Diagnostic Accuracy of 18F-FDG PET and 18F-FES ... In this prospective pilot study, there was no evidence of a difference in diagnostic accuracy of 18 F-FES PET and 18 F-FDG PET in staging patients with grade 1 ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/0284186X.2021.2004323

Feasibility, Safety and Impact of (18F)-FDG PET/CT in ... The aims of the current study were to evaluate the feasibility, safety and impact of (18F)-FDG PET/CT performed during pregnancy.

10. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/333457

Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial ... This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution.