Positron Emission Tomography (PET) Using Hormone Receptor Ligands in 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

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to find a way to learn the hormone receptor status of a tumor before surgery is done. By testing for the hormone receptor proteins, doctors can find out if the breast cancer uses hormones to grow. This is important since the hormone receptor status of a tumor helps doctors decide if extra treatment like chemotherapy or pills are needed.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with a confirmed diagnosis of invasive breast cancer who are undergoing surgery.

PET scan with injection of 5-8 mCi of 18FES

Intervention Type PROCEDURE

Following injection of the tracer 18FES, dynamic images will be obtained for 30 minutes over the chest area to include cardiac region and breasts. Following the first dynamic imaging for 30 minutes, whole body images (base of skull to pelvis) will be obtained at 5 minute/bed position. An additional, longer scan after 60 minutes will be obtained for the chest (1-2-FOV for 15 minutes each). Total time from injection to completion of imaging will be about 90 minutes.

Interventions

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PET scan with injection of 5-8 mCi of 18FES

Following injection of the tracer 18FES, dynamic images will be obtained for 30 minutes over the chest area to include cardiac region and breasts. Following the first dynamic imaging for 30 minutes, whole body images (base of skull to pelvis) will be obtained at 5 minute/bed position. An additional, longer scan after 60 minutes will be obtained for the chest (1-2-FOV for 15 minutes each). Total time from injection to completion of imaging will be about 90 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male and Female patients
* Aged 18 or older at the time of breast cancer diagnosis
* Patients with invasive breast cancer at least 1 cm in size. Patients who have had a prior surgical excision are eligible provided there is a residual of at least a 1 cm area suspected on imaging studies.
* Histopathologic review at MSKCC confirming diagnosis of invasive breast cancer (ductal, lobular, or inflammatory breast cancer).
* Patients who are operative candidates. Patient will have surgery to include either mastectomy or lumpectomy. Radiologic assisted excisions such as needle localization are also eligible.
* Patients with bilateral breast cancer are eligible.
* Patients with metastatic cancer, provided they need surgical biopsy.
* Patients who are undergoing sentinel node mapping (day before or sameday mapping).
* Patient must sign informed consent.

Exclusion Criteria

* Previous or concurrent malignancy (except basal and squamous skin cancer and stage 0 cervical cancer)
* Patients who are pregnant or nursing
* Patients unable to tolerate PET or PET/CT
* Patients with known active infection, autoimmune or inflammatory disease such as sarcoidosis, and rheumatoid arthritis.
* Patients with non invasive breast cancer such as DCIS.
* Patients who have received prior radiation therapy to the affected breast.
* Patients who have received prior chemotherapy, including neoadjuvant chemotherapy or hormonal therapy for breast cancer.
* Patients living in a residential care or correctional facility.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No