Completed

Pilot Study: High Risk Breast Cancer Screening Pilot Study

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What is being tested

motexafin gadolinium

+ biopsy

+ breast imaging study

DrugProcedure
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

From 25 to 120 Years
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: June 1999
See protocol details

Summary

Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: September 24, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer. Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer. OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical examination, mammography, or MRI undergo a core needle or excisional biopsy. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 2 years.

NCT00003736
Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: September 24, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 25 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

DISEASE CHARACTERISTICS: Patients at greater than 25% lifetime risk for breast cancer on the basis of family history or a genetic test Prior breast cancer allowed if patient meets the greater than 25% lifetime risk Patients with greater than 5 years since diagnosis must have at least 50% probability for developing breast cancer by the Couch model or be positive for BRCA1 or BRCA2 mutation Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 25 and over 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 contraindications to MRI scan including patients with pacemakers, magnetic aneurysm clips or other implanted magnetic devices, or severe claustrophobia Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

UCSF Cancer Center and Cancer Research Institute

San Francisco, United StatesOpen UCSF Cancer Center and Cancer Research Institute in Google Maps

University of Colorado Cancer Center

Denver, United States

Porter Adventist Hospital

Denver, United States

Hartford Hospital

Hartford, United States
Completed12 Study Centers