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Evaluation of a New Multi-modality Visualization Tool for Investigation of Breast Lesions


N/A
21 Years
80 Years
Not Enrolling
Female
Breast Lesions

Thank you

Trial Information

Evaluation of a New Multi-modality Visualization Tool for Investigation of Breast Lesions


Inclusion Criteria:



- Patients with MRI-identified lesions that cannot be visualized under the second-look
ultrasound examination, and who will undergo the recommended unilateral MRI
follow-up.

Exclusion Criteria:

- US-visible lesion.

- Any contraindications to MRI (e.g., pacemakers, metal implants).

- Any contraindications to US imaging.

- Pregnancy.

- Claustrophobia.

- Inability to lie still for 45 minutes-1 hour.

- In excess of 250 pounds.

- Incapability to provide informed consent.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Target identification success: this outcome measure is a 'yes/no' outcome, indicating whether or not an MRI-detected lesion could be successfully visualized using US-guidance in the supplemental US exam

Outcome Time Frame:

Time of examination

Safety Issue:

No

Principal Investigator

Petrina Causer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Center

Authority:

Canada: Ethics Review Committee

Study ID:

049-2009

NCT ID:

NCT00934297

Start Date:

July 2009

Completion Date:

July 2011

Related Keywords:

  • Breast Lesions
  • MRI visible breast lesions that are occult under ultrasound

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