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21DIF039: Prone to Supine Breast MRI II, P2S2 Breast MRI Trial

NCT05131607 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-01-30

No results posted yet for this study

Summary

The purpose of this study is to determine whether a supine breast MRI obtained with a second intravenous injection of gadolinium contrast immediately after a standard clinical prone breast MRI will provide sufficient tumor visualization to allow a Radiologist to define and outline the tumor edges ("segment" the tumor). Accurate segmentation will allow a 3-D image of the tumor to be generated to create a breast cancer locator (BCL) surgical device to in aid removal of breast cancers.

Conditions

  • Breast Cancer Female

Interventions

PROCEDURE

Supine MRI

After completion of the standard prone MRI sequences the patient will be positioned supine, coils will be placed and baseline images will be obtained. Then a second dose of contrast equal to the first dose will be given, and additional images will be obtained

Sponsors & Collaborators

  • CairnSurgical, Inc.

    collaborator INDUSTRY

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Roberta diFlorio-Alexander, MD · DHMC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2023-07-03
Completion
2024-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131607 on ClinicalTrials.gov