Effects of Gadobutrol on background parenchymal enhancement in breast dynamic MRI

Effects of Gadobutrol on background parenchymal enhancement in breast dynamic MRI - Effects of Gadobutrol on background parenchymal enhancement in breast dynamic MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026386

Enrollment

120

Registered

2017-03-06

Start date

2017-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who are scheduled to undergo breast dynamic MRI for breast cancer or suspected breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: -Patients who are scheduled to undergo breast MRI for breast cancer or suspected breast cancer -Patients aged 20 to less than 70 years -Patients with information on menstrual cycles available, if premenopausal -Both the inpatient and outpatient settings are acceptable

Exclusion criteria

Exclusion criteria: -Patients with known hypersensitivity to gadolinium-based contrast agents -Patients with renal impairment (e-GFR : less than 30mL/min/1.73m2) -Pregnant, Parturient or breastfeeding women -Patients who experienced breast cancer in the past, with invasive treatment -Patients receiving drug therapy for breast cancer -Patients who are inappropriate for enrolment for any other reason in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
To determine the effect of background parenchymal enhancement on contrast during the early phase of breast dynamic MRI using background : lesion-to-background contrast with gadobutrol will be compared with the large-scale data	—

Secondary

Measure	Time frame
To characterize the TIC of gadobutrol-enhanced breast dynamic MRI : The TIC will be compared with previous reports and discussed	—

Countries

Japan

Contacts

Public ContactIkumi Waki

Hakuaikai Social Medical Corporation Sagara Hospital Clinical Research Center

i-waki1031@sagara.or.jp099-224-1800

Outcome results