NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Comparison of CE-DBT and MRI in Patients With Known Breast Lesions

TerminatedEARLY_Phase 1

Sponsor: UNC Lineberger Comprehensive Cancer Center

Conditions: Breast Cancer

Interventions: Iohexol 350 Mg/mL Injectable Solution

Countries: United States

The purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (CE- DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI) acquired as a part of a standard clinical workup.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Women at least 18 years old
* Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan
* Suspected breast lesion based on prior imaging (BIRADS 4 or greater)
* Able to provide written informed consent

Exclusion Criteria:

* Severe untreatable claustrophobia
* Implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants)
* Known hypersensitivity to iodinated contrast agent or to any component of iodinated contrast refractory to standard medications (antihistamines, steroids)
* Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels within the last 30 days prior to the research scan) unless anuric and on dialysis
* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the UNC IRB SOP 4801)

Locations (1)

Chapel Hill, North Carolina, United States