PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT Trial)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201942
• Other study ID #: CTA-Control-092493
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 17, 2007
• Start date: February 2005
• Est. completion date: May 2007

Study information

• Verified date: October 2007
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The overall goal of this study is to determine how FDG-PET can be incorporated into the assessment of the axilla in the staging and treatment of women with early stage breast cancer.

A multicentre, prospective, diagnostic accuracy study will be conducted evaluating the ability of positronic emission tomography using fluorodeoxyglucose (FDG-PET) to detect the presence or absence of axillary lymph node metastases in newly diagnosed breast cancer patients with no clinical evidence of spread of disease beyond the breast.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• PET scan

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	St. Joseph's	Hamilton	Ontario
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	North York	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	St. Michael's	Toronto	Ontario
Canada	Sunnybrook Regional Cancer Centre and Women's College	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	Patients with positive FDG-PET in non-axillary nodal areas;
Secondary	Patients with positive FDG-PET in other non-nodal areas;
Secondary	Patients with positive FDG-PET in the residual breast tissue.