Positron Emission Tomography (PET) Using Hormone Receptor Ligands in Breast Cancer
August 12, 2015 updated by: Memorial Sloan Kettering Cancer Center
PET Using Hormone Receptor Ligands in Breast Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
79
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Breast Clinic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Patients with a confirmed diagnosis of invasive breast cancer who are undergoing surgery.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To use estrogen-like ligands labeled with positron emitters to preoperatively evaluate the estrogen receptor (ER) status of breast cancer on PET imaging.
Time Frame: conclusion of the study
|
conclusion of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To correlate ER positivity on PET ligand imaging, and conventional immunohistochemical pathologic analysis of ER positivity in surgical specimens.
Time Frame: conclusion of the study
|
conclusion of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mary Gemignani, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
March 28, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 12, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.