Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities

NCT ID: NCT02406274

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2024-06-27

Brief Summary

Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. This dye is the same dye that is used for CT scans. This type of mammogram includes a regular mammogram as well as additional pictures with the dye.

This particular study is being done to determine if by adding the dye in the veins the investigators are better able to identify the cause of the lump than if they just did the regular mammogram alone.

Conditions

Breast Abnormalities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Contrast Enhanced Spectral Mammography

Group Type: EXPERIMENTAL

Contrast Enhanced Spectral Mammography (CESM)

Intervention Type: OTHER

Women presenting to MSKCC with a palpable abnormality within the breast either self palpated \& or palpated by their physician will be offered CESM instead of FFDM alone. The breast imager assigned to care for the patient will interpret the low energy images (including any additional views they routinely obtain) \& record their findings. They will then interpret the CESM \& record those results. As per standard of care, the patient will have a targeted ultrasound as well. Appropriate clinical recommendations will be made. In patients with no specific imaging findings, follow-up will be determined by the degree of suspicion of the palpable finding \& will either be called negative \& followed clinically if not suspicious, or will go on to MRI , percutaneous biopsy by a surgeon or surgical biopsy if suspicious.

Interventions

Contrast Enhanced Spectral Mammography (CESM)

Women presenting to MSKCC with a palpable abnormality within the breast either self palpated \& or palpated by their physician will be offered CESM instead of FFDM alone. The breast imager assigned to care for the patient will interpret the low energy images (including any additional views they routinely obtain) \& record their findings. They will then interpret the CESM \& record those results. As per standard of care, the patient will have a targeted ultrasound as well. Appropriate clinical recommendations will be made. In patients with no specific imaging findings, follow-up will be determined by the degree of suspicion of the palpable finding \& will either be called negative \& followed clinically if not suspicious, or will go on to MRI , percutaneous biopsy by a surgeon or surgical biopsy if suspicious.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician

Exclusion Criteria

• Age < 25 years old
• Male patients
• Pregnant or lactating patients
• Patients with allergy to iodinated contrast
• Patients with a history of renal disease or patients over 70 with a creatinine > 1.3. Creatinine must have been done within the last 12 weeks.

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxine Jochelson, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

15-053

Identifier Type: -

Identifier Source: org_study_id