Tomosynthesis Screening for Breast Cancer

(TMISTLead-in Trial)

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Breast cancer history, Breast enhancements, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breast cancer screening method using a 3D imaging technique called tomosynthesis. Researchers aim to determine if combining this method with standard 2D mammograms improves accuracy in detecting breast cancer compared to the standard method alone. Women over 40, scheduled for a routine mammogram and without symptoms of breast disease, may qualify for this study. Participants will receive either the traditional mammogram or the enhanced version with tomosynthesis. As an unphased trial, this study provides participants the chance to contribute to the advancement of breast cancer screening technology.

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

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 tomosynthesis is safe for breast cancer screening?

Research shows that using digital breast tomosynthesis (DBT) with regular two-dimensional mammography (FFDM) is generally safe for breast cancer screening. Evidence suggests that DBT detects more cancers and reduces the need for additional testing compared to digital mammography alone.

Studies have not identified any major safety issues with DBT. Its widespread use in breast cancer screening indicates that most patients tolerate it well. Although specific side effects are not detailed in the studies, the common use of DBT in medical settings supports its safety.

In summary, available evidence suggests that DBT is a safe choice for breast cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tomosynthesis for breast cancer screening because it offers a potentially more detailed and accurate imaging method compared to the standard digital mammograms. Unlike traditional 2D mammograms, tomosynthesis creates a 3D picture of the breast by taking multiple X-ray images from different angles. This technique can help doctors better detect small or obscured tumors, reducing false positives and minimizing unnecessary biopsies. By improving detection, tomosynthesis could lead to earlier and more accurate diagnoses, which is a crucial factor in effective breast cancer treatment.

What evidence suggests that tomosynthesis is effective for breast cancer screening?

Research has shown that digital breast tomosynthesis (DBT), which participants in this trial may receive, often detects more breast cancers and results in fewer unnecessary follow-up tests compared to standard 2D mammograms. Studies have found that DBT can catch cancer earlier and reduce false positives, where the test wrongly suggests cancer. This means fewer women need to return for extra tests unnecessarily. Overall, DBT is linked to a slight decrease in breast cancer deaths and a small improvement in quality of life. ^{2 6 7 8 9}

Who Is on the Research Team?

Roberta A Jong, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for asymptomatic women aged 40 and over who are scheduled for a routine screening mammogram. Participants must be able to undergo digital breast tomosynthesis and full-field digital mammography, and provide consent. Women with prior breast cancer, current or planned pregnancy, recent mammograms, breast enhancements, or new breast complaints cannot join.

Inclusion Criteria

I am scheduled for a screening mammogram.

I am a woman over 40 and do not have any symptoms.

Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol

Exclusion Criteria

I am experiencing symptoms of breast disease and need a mammogram.

I have noticed new issues with my breast, like a lump or discharge.

Pregnancy or intent to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either DBT plus FFDM or FFDM alone for breast cancer screening

3 years

Three consecutive screening rounds

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Standard of care imaging follow-up

Reader Studies

Assessment of different combinations of FFDM, tomosynthesis, and synthesized FFDM images

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Tomosynthesis

Trial Overview The study aims to compare the effectiveness of two types of breast cancer screenings: one combining three-dimensional digital breast tomosynthesis (DBT) with standard two-dimensional full-field digital mammography (FFDM), versus FFDM alone in detecting cancer.

How Is the Trial Designed?

Group I: Tomosynthesis + FFDM Experimental Treatment 1 Intervention

Women enrolled to DBT Arm will undergo manufacturer-defined DBT

Group II: FFDM - Standard of Care for Screening Active Control 1 Intervention

Women enrolled to the FFDM Arm will undergo bilateral digital mammogram with standard CC and MLO views acquired

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Recruited

153,000+

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. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.230306

Breast Cancer Screening with Digital ... Many previous studies have demonstrated that DBT improves the cancer detection rate and reduces the recall rate compared with digital mammography (DM) alone.

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

Breast Cancer Screening Using Mammography, Digital ... Outcome trade-offs shown are false-positive recalls per breast cancer death averted and false-positive biopsy recommendations per breast cancer ...

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

Mammography screening outcomes for women ... This study compared breast cancer screening outcomes between high resolution (HR; 70-micron) and standard resolution (SR; 100-micron) digital breast ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7301096/

Long-Term Outcomes and Cost-Effectiveness of Breast ... Compared to DM, DBT screening resulted in a slight reduction in breast cancer deaths (range across models 0–0.21 per 1000 women), small increase in QALYs (1.97– ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39186304/

Breast Cancer Screening Using Mammography ... - PubMed Importance: Information on long-term benefits and harms of screening with digital breast tomosynthesis (DBT) with or without supplemental breast ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf8/p080003s001b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The objective was to compare the clinical performance of three dimensional breast tomosynthesis images with a synthesized 2D image (3DS) to that ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624000985

Digital breast tomosynthesis for breast cancer diagnosis in ... This systematic review compares the clinical effectiveness and cost-effectiveness of DBT, digital mammography (DM), and ultrasound, for breast cancer detection ...

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

Recommendation: Breast Cancer: Screening Association of screening with digital breast tomosynthesis vs digital mammography with risk of interval invasive and advanced breast cancer.