search
Back to results

Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of breast cancer for which surgical intervention is planned Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR Locally advanced breast cancer (T4) OR Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR Locally or regionally recurrent disease No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ) No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix No known active infection No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis) Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positron Emission Tomography

Arm Description

Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.

Outcomes

Primary Outcome Measures

Determine the sensitivity, specificity, and accuracy

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
December 23, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00039286
Brief Title
Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
Official Title
A Pilot Study To Assess The Utility Of 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) In The Pre-Operative Evaluation Of Patients With Primary And Recurrent Breast Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the ability to detect the extent of breast cancer. PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer.
Detailed Description
OBJECTIVES: Determine the sensitivity, specificity, and accuracy of fludeoxyglucose F 18 (FDG) positron emission tomography (PET) as compared to conventional imaging in determining the extent of disease in women with primary or recurrent breast cancer. Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings. Determine whether FDG-PET results in more accurate detection of disease in these patients. OUTLINE: Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months. PROJECTED ACCRUAL: (50 with primary disease and 50 with recurrent disease) will be accrued for this study within 1-2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positron Emission Tomography
Arm Type
Experimental
Arm Description
Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Type
Procedure
Intervention Name(s)
radionuclide imaging
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Primary Outcome Measure Information:
Title
Determine the sensitivity, specificity, and accuracy
Time Frame
2 years

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of breast cancer for which surgical intervention is planned Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR Locally advanced breast cancer (T4) OR Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR Locally or regionally recurrent disease No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ) No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix No known active infection No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis) Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Rush Port, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer

We'll reach out to this number within 24 hrs