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NCT01925170 · ClinicalTrials.gov registry record · NA

Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

A NA study, sponsored by Mayo Clinic.

Completed
Registry status
NA
Development phase
1,638
Enrollment target

NCT01925170: Completed NA study, sponsored by Mayo Clinic.

NCT01925170 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 1,638 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01925170, a NA study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
NA
Development phase
1,638 participants
Enrollment target

Study Summary

A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive than mammography for detecting breast cancer in women with dense breasts. The purpose of this study is to see if MBI using a low dose of gamma radiation can find cancers not seen on mammography. Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal or higher positive predictive value than SM in women age 40 and older with mammographically dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive rate (specificity \>90%) that permits its use as a screening tool in this patient population.

Primary Outcome

The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.

Interventions

  • DEVICE Molecular Breast Imaging
  • DEVICE Conventional Mammography
  • DRUG Technetium (99mTc) sestamibi

Trial Details

FieldValue
Enrollment Target 1,638 participants
Start Date 2009-04
Est. Completion 2013-06
Phase NA
Mayo Clinic

2,844 total trials

What the finished NCT01925170 record still lists

NCT01925170 is an interventional study that assigns participants to a tested intervention. Its 1,638 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (17% higher).

The record links to 0 conditions, and to 3 interventions - of which Molecular Breast Imaging is the first listed.

NCT01925170 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01925170 about?

NCT01925170 is a clinical study titled "Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts". A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive than mammography for detecting breast cancer in women with dense breasts. The purpose of this study is to see if MBI using a low dose of gamma radiation can find cancers not seen on mammography. Hypotheses:...

What is the current status of trial NCT01925170?

This trial is currently completed. It is a NA study. The enrollment target is 1,638 participants. The study started on 2009-04. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01925170?

The interventions under investigation include: Molecular Breast Imaging (DEVICE), Conventional Mammography (DEVICE), Technetium (99mTc) sestamibi (DRUG).

Who is sponsoring clinical trial NCT01925170?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01925170's enrollment target sits among peer trials

1,638 63rd of 2000 higher than 1,938 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01925170, the US trial registry maintained by the National Library of Medicine. NCT01925170 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.