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


Phase 0
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

assess the diagnostic accuracy

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Gary Ulaner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

11-177

NCT ID:

NCT01864083

Start Date:

May 2013

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • FACBC PET/PEM
  • MR
  • 11-177
  • Breast Neoplasms

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021