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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

PET scan

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Diagnosis, PET, Positronic Emission Tomography, fluorodeoxyglucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Outcomes

Primary Outcome Measures

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 Outcome Measures

Patients with positive FDG-PET in non-axillary nodal areas;

Patients with positive FDG-PET in other non-nodal areas;

Patients with positive FDG-PET in the residual breast tissue.

Full Information

NCT ID

NCT00201942

First Posted

September 13, 2005

Last Updated

October 17, 2007

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

1. Study Identification

Unique Protocol Identification Number

NCT00201942

Brief Title

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

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Diagnosis, PET, Positronic Emission Tomography, fluorodeoxyglucose

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

336 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

PET scan

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Patients with positive FDG-PET in non-axillary nodal areas;

Title

Patients with positive FDG-PET in other non-nodal areas;

Title

Patients with positive FDG-PET in the residual breast tissue.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials: