New Technique as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection. Preliminary patient studies with our dual-detector system indicate that this system is capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor uptake and washout may be predictors to response to neoadjuvant therapy for patients with the diagnosis of breast cancer. We propose that in patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an accurate test for assessing response rate to neoadjuvant therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer

NCT01023802

Neoadjuvant Therapy Chemotherapy Hormone Replacement Therapy +1 more

COMPLETED

Molecular Breast Imaging in Patients With a History of Bloody Nipple Discharge

NCT00566280

Breast Cancer Bloody Nipple Discharge

COMPLETED NA

Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities

NCT06058650

Breast Neoplasm

RECRUITING NA

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

NCT01925170

Breast Cancer

COMPLETED NA

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

NCT00620373

Breast Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Adjuvant therapy after surgery for breast cancer has provided significant benefits to patients at risk for relapse. However, the success of therapy for each individual patient will often take years to reveal. Preoperative (neoadjuvant) medical therapy is very potent as an initial treatment for inoperable and large operable breast cancers. Tumor regression can be achieved in the great majority of patients and downstaging frequently reduces the need for mastectomy and it has become clear that pathologic complete response is a good prognostic marker. Data from current trials suggest that survival is at least as good with preoperative as with postoperative neoadjuvant therapies (1). With this observation preoperative medical therapy has the advantage over post-operative neoadjuvant therapy that it can be used as a short term surrogate marker for long-term outcome. With this translational approach, the therapy for each patient can be more targeted and individualized leading to higher success rates; and further, new therapies for early breast cancer can be assessed much more quickly than is currently possible through protracted trials of neoadjuvant therapy (2). This approach is therefore being increasingly utilized in patients with lower stage breast cancers.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Molecular Breast Imaging

Group Type OTHER

Molecular Breast Imaging

Intervention Type PROCEDURE

A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 28-32 mCi of 99m Tc-sestamibi.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Molecular Breast Imaging

A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 28-32 mCi of 99m Tc-sestamibi.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MBI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women age 18 - 90
* Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy
* Women who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery