Advanced Imaging Techniques for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Advanced cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of different imaging techniques, such as MRI (Magnetic Resonance Imaging), digital mammography, ultrasound, and PET scans, in detecting and understanding breast cancer. The goal is to compare and integrate these tools to provide doctors with a clearer picture of the cancer's extent. Women recently diagnosed with breast cancer and planning surgery at the Hospital of the University of Pennsylvania may be suitable candidates. This study aims to improve breast cancer diagnosis and treatment through advanced imaging methods. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could enhance breast cancer diagnosis and treatment for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these imaging techniques are safe for breast cancer diagnosis?

Research has shown that the four imaging techniques in this study—digital mammography, MRI, PET, and ultrasound—are generally safe for people.

Digital mammography uses X-rays to capture breast images. It is well-tolerated and safe for breast cancer screening, with no major side effects reported.

MRI (magnetic resonance imaging) is also safe. This non-invasive test uses magnets and radio waves instead of radiation. Some individuals might feel temporary warmth, but it is generally well-tolerated. Safety checks address any potential risks beforehand.

PET (positron emission tomography) scans use a small amount of radioactive material to highlight problem areas. These scans are minimally invasive, and while they involve radiation, the amount is low and safe for diagnostic purposes. Research has shown PET scans can effectively help diagnose breast cancer without major side effects.

Ultrasound uses sound waves to create images. It is a safe, non-invasive method with no radiation exposure. There is no significant risk associated with its use, making it a reliable option for breast imaging.

Overall, these imaging techniques are well-established and widely used to help diagnose breast cancer. They are safe for patients, with minimal risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of advanced imaging techniques for breast cancer because they offer a more comprehensive and detailed view of tumors compared to traditional methods like standard mammography. Digital mammography, MRI, PET, and ultrasound each provide unique insights into the structure and activity of breast tissue, potentially leading to earlier and more accurate diagnosis. Moreover, these techniques can identify the exact location and extent of cancer, which is crucial for tailoring personalized treatment plans. By integrating these advanced methods, doctors hope to improve detection rates and treatment outcomes, ultimately enhancing patient care.

What evidence suggests that these imaging techniques are effective for diagnosing breast cancer?

This trial will evaluate advanced imaging techniques for breast cancer. Research has shown that digital mammography can reduce the risk of dying from breast cancer by 22% for women who undergo screening. MRI (magnetic resonance imaging) excels at detecting early-stage breast cancer, with a high accuracy rate of 96%. PET (positron emission tomography) surpasses traditional methods in identifying cancer that has spread, potentially leading to better treatment outcomes. Ultrasound proves useful in detecting cancers that mammograms might miss, particularly in women with dense breast tissue. Each imaging method offers unique strengths in detecting and managing breast cancer, and this trial will explore their effectiveness in patients diagnosed with the disease. ^{2 6 7 8 9}

Who Is on the Research Team?

Abass Alavi, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for women recently diagnosed with breast cancer who will have surgery at the Hospital of the University of Pennsylvania. It's not for pregnant women, those treated with preoperative therapy for advanced cancer, anyone with MRI contraindications, or a past diagnosis in the same breast within 5 years.

Inclusion Criteria

I will have surgery at the Hospital of the University of Pennsylvania after the study.

I have been recently diagnosed with breast cancer.

Exclusion Criteria

I was diagnosed with breast cancer in the same breast within the last 5 years.

Pregnant women

I am receiving initial treatment for my advanced cancer before any surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo diagnostic imaging using MRI, DMAM, ultrasound, and PET to determine the extent of breast cancer

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Mammography
• MRI
• PET
• Ultrasound

Trial Overview The study compares four imaging techniques—MRI, digital mammography (DMAM), ultrasound, and PET scans—to see how well they work together to determine the extent of breast cancer before surgery.

How Is the Trial Designed?

Group I: Patients Diagnosed with Breast Cancer Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a study of 9,208 women aged 40 to 64, those who underwent breast MRI experienced significantly more downstream medical events (39 additional mammary events and 19.6 additional extramammary events per 100 women) compared to those who had mammograms.

Breast MRI also resulted in higher overall healthcare costs, with an increase of $1,404 per woman in total spending and $31 more in out-of-pocket expenses, suggesting that while MRI may provide more information, it also leads to more procedures and costs that may not always be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Downstream Mammary and Extramammary Cascade Services and Spending Following Screening Breast Magnetic Resonance Imaging vs Mammography Among Commercially Insured Women. Ganguli, I., Keating, NL., Thakore, N., et al.[2022]

Emerging breast imaging modalities, such as digital breast tomosynthesis (DBT) and molecular breast imaging, show promise in addressing the limitations of traditional mammography for various purposes including screening and diagnosis.

These new techniques may enhance the accuracy of breast cancer detection and treatment planning, potentially improving outcomes for patients, especially those at high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging breast imaging modalities. Rush, B.[2012]

Early diagnosis and accurate treatment of breast cancer can lead to a cure in 90% of cases, highlighting the critical role of diagnostic imaging in improving disease outcomes.

Recent advancements in imaging techniques, such as MRI and PET-CT, enhance the detection and characterization of breast cancer, although none can provide a definitive histological diagnosis without imaging-guided biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of imaging in the diagnostic and therapeutic algorithms of breast cancer]. Godény, M., Szabó, E., Bidlek, M., et al.[2016]

In a study of 45 breast cancer patients and 35 benign tumor patients, key MRI indicators for diagnosing breast cancer were identified, including tumor edge features, time-signal intensity curve (TIC) types, and apparent diffusion coefficient (ADC) values at b=500 s/mm2.

The combination of conventional MRI, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced MRI provided the best diagnostic approach, with magnetic resonance spectroscopy (MRS) serving as a useful supplementary tool for challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimization of diagnosis indicator selection and inspection plan by 3.0T MRI in breast cancer]. Jiang, Z., Wang, Y., He, Z., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8757313/

Comparative Effectiveness of Digital Breast Tomosynthesis ... Digital breast tomosynthesis (DBT) may have a higher cancer detection rate and lower recall compared with 2-dimensional (2 D) mammography for breast cancer ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0899707125001536

Mammography screening outcomes for women ... Due to improvements in screening and treatment, breast cancer mortality has steadily decreased by 44 % between 1989 and 2022 (3). Mammographic imaging is the ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2822381

Breast Cancer Screening Using Mammography, Digital ... With annual screening, average deaths averted for DBT screening ranged from 8.9 to 10.4 years across initiation ages. Relative to DM for all ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.231533

Digital Breast Tomosynthesis versus Digital Mammography ... Mammography screening is an effective tool for breast cancer mortality reduction; it reduces mortality by 22% among women invited to screening ...

5. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening

Recommendation: Breast Cancer: Screening Both digital mammography and digital breast tomosynthesis (DBT, or “3D mammography”) are effective mammographic screening modalities. DBT must ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3939224/

Comparison of standard mammography with digital ... This review of the scientific literature aims to assess the safety and efficacy of screen-film mammography (SFM) and ultrasonography compared to FFDM and DITI

7. cancer.gov cancer.gov/types/breast/mammograms-fact-sheet

Mammograms - NCI A mammogram is an x-ray picture of the breast. Mammograms can be used to check for breast cancer in women who have no signs or symptoms of the disease.

8. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/15939-digital-breast-tomosynthesis-and-breast-cancer-screening

Breast Tomosynthesis Your healthcare provider may order digital breast tomosynthesis if you have breast cancer symptoms, like breast pain, a lump in your breast or skin changes.

9. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2834386

Tomosynthesis vs Digital Mammography Screening in ... In this cohort study of women with a family history of breast cancer, DBT screening reduced recall rates and increased specificity compared to DM.