Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants with a newly diagnosed breast cancer and recommended for enhanced imaging will be randomly assigned to either CEM or MRI and take the State-Trait Anxiety Inventory (STAI) before and after imaging.

Participants with a newly diagnosed breast cancer and recommended for enhanced imaging but who cannot or choose not to be randomly assigned to CEM or MRI but they consent to take the State-Trait Anxiety Inventory (STAI) before and after imaging.

The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.

State-Trait Anxiety Inventory (STAI)

Jordana Phillips, MD FSBI

Artem Kaliaev, MD

The investigators will study the financial, time, and psychologic benefit of Contrast Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer evaluation and ultimately encourage practices and referring providers to use it more routinely in practice.

Specific research objectives are to:

* determine financial costs of performing a CEM to breast MRI
* compare time costs involved with CEM to breast MRI
* compare psychologic costs involved with CEM to breast MRI.

Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)

Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment

True institutional costs will be calculated using time-driven activity based costing (TDABC) methodology to estimate the capacity cost rate (CCR, defined as cost per unit time in dollars per minute for personnel, equipment, and fixed equipment) and total cost (TC, defined as the sum of CCR per resource multiplied by time utilization and added to cost of consumable materials) for MRI and CEM.

Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.

Time will be measured in days and abstracted from medical records.

Number of patient visits generated from the imaging modality will be abstracted from medical records.

The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

Breast Cancer Alliance

Boston Medical Center

Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography

Patients in No intervention arm will go through no additional preoperative imaging

Contrast Enhanced Mammography (CEM)

Kristina Ahsberg, PhD

Patients diagnosed with breast cancer after routine assessment with digital mammography and ultrasound and scheduled for primary surgery are included in the trial. The patients are randomized 1:1 to go through additional contrast enhanced mammography (CEM) or no further imaging preoperatively. Primary endpoint is rate of patients with change of treatment: a) mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy instead of primary surgery due to more advanced disease. Rate of reoperation and rate of avoidable mastectomies are secondary endpoints.

Breast cancer is very uncommon among men.

Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions

Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial

Mastectomy instead of partial mastectomy due to findings of multifocal disease, mastectomy instead of partial mastectomy due to larger unifocal extent, partial mastectomy instead of mastectomy due to improved demarcation of tumour area, bilateral surgery due to findings of contralateral cancer, primary neoadjuvant treatment instead of primary surgery due to more advanced disease

Number of reoperations due to inadequate margins

Patients operated with mastectomy where histopathology shows extent less than 3 cm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)	NCT06008301	Breast Cancer F...	State-Trait Anx...	30 Years -	Boston Medical Center
Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions	NCT04437602	Breast Cancer	Contrast Enhanc...	18 Years -	Region Halland
Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)	NCT06008301	Breast Cancer F...	State-Trait Anx...	30 Years -	Boston Medical Center

Spots Global Cancer Trial Database for contrast enhanced mammography (cem)