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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00647790
First received: March 28, 2008
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: PET scan with injection of 5-8 mCi of 18FES

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PET Using Hormone Receptor Ligands in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Serum blood sample postimaging, Serum Estradiol (female only)


Enrollment: 79
Study Start Date: November 2006
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with a confirmed diagnosis of invasive breast cancer who are undergoing surgery.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast Clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647790

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Mary Gemignani, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00647790     History of Changes
Other Study ID Numbers: 05-088
Study First Received: March 28, 2008
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
PET imaging
invasive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014