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A Prospective Study to Determine the Role of 2-[18F]Fluoro-2-Deoxy-D-Glucose (FDG)Positron Emission Tomography (PET)in the Assessment of Regional Nodal Spread of Disease in Breast Cancer Patients


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Prospective Study to Determine the Role of 2-[18F]Fluoro-2-Deoxy-D-Glucose (FDG)Positron Emission Tomography (PET)in the Assessment of Regional Nodal Spread of Disease in Breast Cancer Patients


Patients will have histologic confirmation of invasive breast cancer and will have a FDG-PET
scan prior to axillary node assessment. All patients will have a sentinel node biopsy if
any sentinel nodes can be located. Patients with a positive sentinel node will have an
axillary node dissection. The results of the PET will be compared to the reference standard
of histologic examination of all excised (sentinel and non-sentinel) axillary lymph nodes
which will be referred to as axillary node assessment. Sensitivity, specificity, positive
and negative predictive values for PET-FDG will be determined.


Inclusion Criteria:



- Histologic diagnosis of invasive breast cancer,

- Resectable primary cancer.

Exclusion Criteria:

- The diagnosis of invasive breast cancer was made more than 3 months prior to
registration,

- Patient and/or surgeon are not willing to proceed with a SNB or AND after the PET
scan is completed,

- Patient and/or surgeon are not willing to proceed with a level I and II AND if the
SNB is positive, if the PET scan shows increased uptake in the ipsilateral axilla, or
if the surgeon is still gaining experience in the performance of SNB,

- SNB or AND has already been done,

- Chemotherapy has been given or will be given prior to PET scan or SNB or AND,

- Significant serious concurrent medical problems (e.g., uncontrolled diabetes),

- Patient is pregnant or lactating,

- Patient is unable to lie supine and with both arms above their heads for PET scan,

- Known hypersensitivity to FDG,

- Clinical evidence of regional nodal metastases (fixed, matted axillary nodes),

- Clinical evidence of distant metastases.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary outcomes are the sensitivity and specificity of FDG-PET in axillary node assessments using axillary node assessment [Sentinel Node Biopsy(SNB) with or without Axillary Node Dissection (AND)] as the reference standard.

Principal Investigator

Kathleen Pritchard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sunnybrook Regional Cancer Centre

Authority:

Canada: Health Canada

Study ID:

CTA-Control-092493

NCT ID:

NCT00201942

Start Date:

February 2005

Completion Date:

May 2007

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Diagnosis
  • PET
  • Positronic Emission Tomography
  • fluorodeoxyglucose
  • Breast Neoplasms

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