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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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Breast Cancer Diagnosis PET Positronic Emission Tomography fluorodeoxyglucose

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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PET scan

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Review additional registry numbers or institutional identifiers associated with this trial.

CTA-Control-092493

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

PET scan

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ontario Ministry of Health and Long Term Care

Ontario Clinical Oncology Group (OCOG)

Principal Investigators

Kathleen Pritchard, MD

Claire Holloway, MD

David McCready, MD

Jim Julian, M.Math.

Mark N Levine, MD

Wendy Shelley, MD

Karen Gulenchyn, MD, PhD

Frances O'Malley, MD

Locations

St. Joseph's

Juravinski Cancer Centre

Kingston Regional Cancer Centre

London Regional Cancer Centre

Ottawa Regional Cancer Centre

North York

Sunnybrook Regional Cancer Centre and Women's College

St. Michael's

Mount Sinai Hospital

Princess Margaret Hospital

Countries

Other Identifiers

CTA-Control-092493