FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients

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

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-08-29

Brief Summary

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

This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.

Related Clinical Trials

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

FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

NCT01928186

Estrogen Receptor Positive HER2/Neu Negative Male Breast Carcinoma +7 more

COMPLETED NA

Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer

NCT01018251

Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)

WITHDRAWN NA

Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer

NCT06790264

Breast Cancer Invasive Node Positive Breast Cancer

RECRUITING NA

A Radiotracer ([18F]FluorThanatrace) by PET/CT for the Imaging of Breast Cancer

NCT05226663

Breast Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Using Diagnostic Tools to Stage Breast Cancer

NCT00367666

Breast Cancer

ACTIVE_NOT_RECRUITING NA

Detailed Description

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

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

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Local staging patients

Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard.

Group Type EXPERIMENTAL

Positron Emission Tomography (PET)

Intervention Type PROCEDURE

Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)

Intervention Type DRUG

Positron emission mammography (PEM) When available

Intervention Type PROCEDURE

MR

Intervention Type PROCEDURE

Neoadjuvant chemotherapy patients

Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management.

Group Type EXPERIMENTAL

Positron Emission Tomography (PET)

Intervention Type PROCEDURE

Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)

Intervention Type DRUG

Positron emission mammography (PEM) When available

Intervention Type PROCEDURE

Interventions

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

Positron Emission Tomography (PET)

Intervention Type PROCEDURE

Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)

Intervention Type DRUG

Positron emission mammography (PEM) When available

Intervention Type PROCEDURE

MR

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC
* No prior therapy for IDC or ILC
* Clinical need for local disease staging with breast MR (Group A only)
* Clinical need for neoadjuvant chemotherapy (Group B only)
* Patients must provide written informed consent

Exclusion Criteria

* Age \<21 years
* Men
* Pregnancy or lactation
* Patients who have already started treatment for the current malignancy
* Patients who cannot undergo PET scanning (i.e. because of weight limits)
* Patients who are known to have contraindication for MRI (e.g. metal implants)
* Patients may only participate in group #1 or group #2, but not both

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No