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OpenTrials
Completed

NCT Number: NCT01864083

FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients

This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.

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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

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

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

  • Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC
  • No prior therapy for IDC or ILC
  • Clinical need for local disease staging with breast MR (Group A only)
  • Clinical need for neoadjuvant chemotherapy (Group B only)
  • Patients must provide written informed consent

Exclusion criteria

  • Age <21 years
  • Men
  • Pregnancy or lactation
  • Patients who have already started treatment for the current malignancy
  • Patients who cannot undergo PET scanning (i.e. because of weight limits)
  • Patients who are known to have contraindication for MRI (e.g. metal implants)
  • Patients may only participate in group #1 or group #2, but not both

Treatment and study plan

Positron Emission Tomography (PET)

Procedure

Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)

Drug

Positron emission mammography (PEM) When available

Procedure

MR

Procedure

Primary outcomes

  1. assess the diagnostic accuracy

    Time frame: 2 years

    Accuracy of standardized uptake values will be analyzed by receiver operating characteristic (ROC) curves. ROC curves will be constructed separately for FACBC PET, FACBC PEM and MR. The area under the curve will be used as a summary measure and compared using the standard nonparametric test [20]. We will also consider dichotomizing the uptake and present accuracy using sensitivity, specificity and predictive values. Dichotomized values will be compared using the McNemar test.

  2. ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy

    Time frame: 2 years

    Patients with locally advanced IDC or ILC, requiring neoadjuvant therapy prior to definitive surgery, will undergo FACBC PET and PEM both before chemotherapy and after. Following definitive breast surgery, pathologic specimens will be analyzed to determine if FACBC imaging can predict pathologic treatment response.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 29, 2013
Registry last updated
Aug 31, 2017

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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