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OpenTrials
Completed

NCT Number: NCT01687790

The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease

The primary hypothesis of this project is that using molecular breast imaging (MBI) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy

Exclusion criteria

  • Known contraindication to mammographic imaging
  • women who are pregnant
  • women who are lactating
  • women who have significant existing breast trauma
  • women who have breast implants
  • Women under 18 years of age.
  • women who had previous benign breast surgery within 1 year
  • Males and children
  • Women who are unable to understand or execute written informed consent
  • Women who refuse to have a biopsy
  • Women with any known renal disease - if an MRI is deemed necessary, a serum creatine will be checked prior to injection of contrast. Using the National Kidney Foundation recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive intravenous gadolinium-based MRI contrast. Those individuals with a GFR >30 and <60 can receive the contrast but at a reduced dose (typically half). Those with a GFR <30 will not receive MRI contrast and will not undergo the exam. Breast MRI must be done with contrast if evaluating for cancer. Several factors can affect the GFR such as age, body size, creatinine, renal status and will be calculated from the blood drawn. GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that precludes a Breast MRI with contrast. The final determinant will be the GFR.

Treatment and study plan

molecular breast imaging (Discovery)

Device

Other names: Discovery NM750b

Primary outcomes

  1. Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.

    Time frame: 1 year

    The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).

Secondary outcomes

  1. Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.

    Time frame: 1 year

    Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2012
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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