Positron Emission Tomography (PET) Using Hormone Receptor Ligands in Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: PET scan with injection of 5-8 mCi of 18FES

• Registration Number: NCT00647790
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	PET scan with injection of 5-8 mCi of 18FES	Patients with a confirmed diagnosis of invasive breast cancer who are undergoing surgery.

Primary Outcome Measures

Name	Time	Method
To use estrogen-like ligands labeled with positron emitters to preoperatively evaluate the estrogen receptor (ER) status of breast cancer on PET imaging.	conclusion of the study

Secondary Outcome Measures

Name	Time	Method
To correlate ER positivity on PET ligand imaging, and conventional immunohistochemical pathologic analysis of ER positivity in surgical specimens.	conclusion of the study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States