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Tc99m Sestamibi Molecular Breast Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02324387
Recruitment Status : Active, not recruiting
First Posted : December 24, 2014
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
The goal of this clinical research study is to compare Tc99m sestamibi molecular breast imaging (MBI) scans to mammograms and ultrasounds (the current standard of care) to learn if MBI scans can measure if the disease is responding to chemotherapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Molecular Breast Imaging (MBI) Drug: Tc99m sestamibi Not Applicable

Detailed Description:

If you are found to be eligible to take part in this study and you agree, you will have a total of 3 MBI scans: before you start your already scheduled chemotherapy treatment, after 2 cycles of chemotherapy, and after you complete your chemotherapy treatment but before surgery. You will also receive your standard of care scans.

Before each MBI scan, you will receive an injection of Tc99m sestamibi (a type of drug that gives off energy that is seen with special cameras, like the MBI scan, which creates images of the breast). You will have an MBI scan about 5 minutes after you receive Tc99m sestamibi. During the scan, your breast will be positioned between 2 detectors and lightly compressed. The detectors are 2 square cameras, which look very similar to mammography cameras. The scan should take about 40 minutes.

Information, such as images from previous scans and your medical history, will also be collected from your medical record.

The results from the MBI scans will not affect or change your treatment, including the type of surgery you may have.

Length of Study:

Your active participation on this study will be over after the last MBI scan is completed.

This is an investigational study. MBI scans on this study are performed using FDA-approved and commercially available methods. Tc99m sestamibi is FDA-approved and commercially available. The use of MBI scans to measure how much cancer is in the breast during chemotherapy is considered investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Tumor Response to Neoadjuvant Chemotherapy in Women With Locoregional Invasive Breast Cancer Using Tc99m Sestamibi Molecular Breast Imaging: A Prospective Study
Actual Study Start Date : June 15, 2015
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Molecular Breast Imaging (MBI) + Tc99m sestamibi
Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled chemotherapy treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.
 Procedure: Molecular Breast Imaging (MBI)
Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled neoadjuvant chemotherapy (NAC) treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.
Other Name: MBI

Drug: Tc99m sestamibi
8 mCi of 99mTc sestamibi by vein before each molecular breast imaging (MBI).


Outcome Measures
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Primary Outcome Measures :
  1. Detection of Treatment Response using Molecular Breast Imaging (MBI) plus Tc99m sestamibi [ Time Frame: 24 weeks ]
    Evaluation of treatment response by molecular breast imaging (MBI) tumor to background ratio (T/B), defined as T/B = ROIt_max/ROIb_mean, calculated.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female of 18 years and older of any race
  2. Has biopsy-proven invasive breast cancer (BI-RADS 6) and scheduled for neoadjuvant chemotherapy (NAC).
  3. Newly diagnosed biopsy proven locoregional invasive breast cancer at MD Anderson Cancer Center, or referred to MD Anderson for treatment after initial radiologic (mammographic, sonographic, etc.) exams at an outside institution in whom NAC is planned.
  4. Patients with stage T1 or greater (T1-T4), nodal involvement (N0 - N3), without metastasis (M0) invasive breast cancer, including patients with inflammatory breast cancer.
  5. Patients who agree to sign an informed consent to undergo MBI

Exclusion Criteria:

  1. Is under 18 years of age
  2. Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother
  3. Has lesions involving chest wall
  4. Has known allergy to Tc99m sestamibi
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324387


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Gaiane M. Rauch, MD, PHD M.D. Anderson Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02324387    
Other Study ID Numbers: 2014-0812
NCI-2015-00035 ( Registry Identifier: NCI CTRP )
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Molecular breast imaging
MBI
 Tc99m sestamibi
Neoadjuvant chemotherapy
NAC
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action