RightFit
RecruitingNot applicable

Comparative Performance of Molecular Breast Imaging (MBI) to Magnetic Resonance Imaging (MRI) of the Breast in Identifying and Excluding Breast Carcinoma in Women at High Risk for Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To evaluate the diagnostic performance of Tc99m sestamibi (MBI) compared to breast MRI in women who are at high risk for developing breast cancer."
  • "Primary Objective: -To compare the diagnostic performance of Molecular Breast Imaging (MBI) to breast Magnetic Resonance Imaging (MRI) in women who are at high risk of developing breast cancer."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two breast scans, molecular breast imaging (MBI) and MRI, to see how well they find or rule out breast cancer. It is for women at high risk for breast cancer. It also looks at how a cancer’s size, type, and location affect how well MBI finds it.

To evaluate the diagnostic performance of Tc99m sestamibi (MBI) compared to breast MRI in women who are at high risk for developing breast cancer. To assess the relationship of tumor size, histologic subtype and location of lesion and how it affects lesion conspicuity and sensitivity in MBI detected cancers.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older, of any race, who have a high risk for breast cancer and are referred to MDACC.
  • High risk may mean a lifetime breast cancer risk above 20%, certain abnormal breast cells, or a gene change that raises breast cancer risk.
  • Already scheduled for a breast MRI and willing to have both MRI and MBI scans within two weeks.
  • Willing to have a biopsy if a scan finds a possible cancer. A biopsy takes a tissue sample for testing.
  • Willing to complete a survey about both scans and give written consent to take part. An interpreter will help people who do not speak English.

Who can't join

  • Pregnant women cannot take part. MBI uses an injected radioactive tracer, and MRI uses an injected dye called gadolinium. Neither should be used during pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * The subjects to be studied will include female patients ages 18 and older of any race, identified as carrying an elevated risk for breast cancer referred to MDACC. * High risk may be defined as having a calculated lifetime risk \>20%, histopathology of lobular neoplasia or atypical ductal hyperplasia, atypia NOS or a genetic mutation known to predispose the patient to breast cancer. * Subject who are scheduled for a Breast MRI who are willing to participate fully in all aspects of the study including completing both a Breast MRI \& MBI screening exam within a two-week time window, a biopsy of any positive findings and complete a post examination survey. Consent for the enrollment may be obtained upon scheduling the MRI examination. For non-English speakers, a language interpreter will assist in translation. * Written consent will be obtained from all participants to obtain MBI of the breasts and biopsy as indicated, based on findings. All participants will be asked to provide a post examination survey of their experience with both tests. Exclusion Criteria: * Subjects who are pregnant will be excluded as MBI exam involves injection of radioactive tracer * contrast enhanced MRI involves gadolinium injection, both of which are contraindicated during pregnancy.

Study sites (1)

TX