Comparative Performance of Molecular Breast Imaging (MBI)... | NCT05042687

ID	Type	Description	Link
NCI-2021-09605	Other Identifier	NCI CTRP Clinical Trials Registry

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2021Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Aug 25, 2021

First Submission Date that Met QC Criteria

Sep 8, 2021

First Posted Date

Sep 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2026

Last Update Posted Date

Apr 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Secondary Objectives:

To evaluate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MBI compared to breast MRI in women who are at high risk of developing breast cancer.
To assess patient preference for the two examinations by conducting a post examination survey and follow up questionnaire (see addendum).
To assess the relationship of tumor size, histologic subtype and location of lesion with lesion conspicuity (mild, moderate, marked uptake compared to background activity) according to MBI lexicon [1].

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tc99m sestamibi	Experimental	MBI uses an injection of a small amount of radioactive material called technetium99m (Tc99m) sestamibi	Drug: Tc99m sestamibi

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tc99m sestamibi	Drug	Given by IV	Tc99m sestamibi

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To establish 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		through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Beatriz Adrada	Contact	(713) 792-2709		beatriz.adrada@mdanderson.org

Overall Officials

Name	Affiliation	Role
Beatriz Adrada	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D015609	Organotechnetium Compounds
D009942	Organometallic Compounds