Clinical trial NCT00201942: PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Diagnosis
PET
Positronic Emission Tomography
fluorodeoxyglucose
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2005-09-20
Enrollment: 336
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
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.
Secondary outcomes:
measure: Patients with positive FDG-PET in non-axillary nodal areas;
measure: Patients with positive FDG-PET in other non-nodal areas;
measure: Patients with positive FDG-PET in the residual breast tissue.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: North York
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Regional Cancer Centre and Women's College
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Regional Cancer Centre
name: Kathleen Pritchard, MD
role: STUDY_CHAIR
affiliation: Sunnybrook Regional Cancer Centre
name: Claire Holloway, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Canada
name: David McCready, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Jim Julian, M.Math.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark N Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kingston Regional Cancer Centre
name: Wendy Shelley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Karen Gulenchyn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Frances O'Malley, MD
role: PRINCIPAL_INVESTIGATOR
References: