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OpenTrials
Completed

NCT Number: NCT00039286

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

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.

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Key information

Age range

Up to 120 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positron Emission Tomography

Procedure

radionuclide imaging

Procedure

fludeoxyglucose F 18

Radiation

Primary outcomes

  1. Determine the sensitivity, specificity, and accuracy

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Jan 27, 2003
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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