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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00647790
First received: March 28, 2008
Last updated: November 29, 2012
Last verified: November 2012
History of Changes

March 28, 2008
November 29, 2012
November 2006
November 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647790 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Positron Emission Tomography (PET) Using Hormone Receptor Ligands in Breast Cancer
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum blood sample postimaging, Serum Estradiol (female only)
Non-Probability Sample

Breast Clinic
Breast Cancer
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.
1
Patients with a confirmed diagnosis of invasive breast cancer who are undergoing surgery.
Intervention: Procedure: PET scan with injection of 5-8 mCi of 18FES
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
79
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00647790
05-088
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Department of Defense
Principal Investigator: Mary Gemignani, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP