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

Breast Cancer Clinical Trial

Official title:

PET Using Hormone Receptor Ligands in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647790
• Other study ID #: 05-088
• Status: Completed
• Phase: N/A
• First received: March 28, 2008
• Last updated: August 12, 2015
• Start date: November 2006
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To correlate ER positivity on PET ligand imaging, and conventional immunohistochemical pathologic analysis of ER positivity in surgical specimens.		conclusion of the study	No

External Links

•   Memorial Sloan-Kettering Cancer Center