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NCT Number: NCT00647790

Positron Emission Tomography (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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET scan with injection of 5-8 mCi of 18FES

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

PET Using Hormone Receptor Ligands in Breast Cancer

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Apr 1, 2008
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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