Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03929822|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Screening||Diagnostic Test: Contrast-Enhanced Spectral Mammography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy|
|Actual Study Start Date :||April 23, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Contrast-Enhanced Spectral Mammography (CESM)
Women called back from an abnormal screening mammogram/tomosynthesis exam will be offered CESM as part of their diagnostic work up. The radiologist will interpret the low energy images and record their findings.
Diagnostic Test: Contrast-Enhanced Spectral Mammography
A standard dose of contrast material for other contrast mammography examinations and for body CT scanning, 1.5 ml/kg of Iohexol350 will be injected intravenously (IV) using a power injection (3-4 ml/s) with a maximum does of 150 ml. The IV injection is performed while the patient is in a sitting position. The mammogram will be performed in a standing position.
- Diagnostic accuracy of CESM compared to mammography [ Time Frame: 2 years ]The radiologist will interpret the low energy images and record their findings.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929822
|Contact: Janice Sung, MDfirstname.lastname@example.org|
|Contact: Maxine Jochelson, MD||646-888-4507|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Janice Sung, MD 646-888-5423|
|Contact: Maxine Jochelson, MD 646-888-4507|
|Principal Investigator: Janice Sung, MD|
|Principal Investigator:||Janice Sung, MD||Memorial Sloan Kettering Cancer Center|