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

NCT05131607 | Unknown DMC

• 1 other identifier: STUDY02001039
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Difference in mean tumor-to-fibroglandular contrast ratio in prone compared to supine breast MRI

  Determine the mean tumor-to-fibroglandular contrast in a two bolus intravenous contrast injection prone to supine breast MRI study and compare this to the mean tumor-to-fibroglandular contrast of a single-contrast injection prone to supine breast MRI study.

  Day of standard clinical MRI, 1 day

Secondary Outcomes (1)

• Evaluate tumor visualization and segmentability on supine breast MRI exam with additional contrast injection obtained immediately after prone contrast breast MRI, and compare to tumor visualization and segmentability on clinical prone breast MRI.

  Day of MRI, 1 day

Other Outcomes (1)

• Evaluate time required for double contrast prone to supine exam compared to single contrast prone to supine exam.

  Day of MRI, 1 day

Study Arms (1)

Supine MRI

EXPERIMENTAL

Procedure: Supine MRI

Interventions

Supine MRI PROCEDURE

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

Also known as: Prone to Supine Breast MRI II, P2S2 MRI Trial

Supine MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Female gender.
• Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ.
• Tumor size at least 1 cm in diameter as visualized on mammogram or US.
• A staging, pre-operative breast MRI is considered to be clinically indicated.
• Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.

You may not qualify if:

• Absolute contraindication to MRI, including presence of implanted electrical device. (pacemaker or neurostimulator incompatible with MRI), aneurysm clip, or metallic foreign body in or near eyes.
• Severe claustrophobia.
• Contraindication to the use of gadolinium-based intravenous contrast, including anaphylaxis. Any known history of nephrogenic systemic fibrosis (NSF).
• History of median sternotomy.
• Pregnancy. All women of child-bearing age will be questioned about possible pregnancy status. In women who are unsure of pregnancy status, a urine pregnancy test will be performed.
• Patients who have received neoadjuvant chemotherapy for their current diagnosis.
• Known compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• CairnSurgical, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 05055, United States

Location

Study Officials

• Roberta diFlorio-Alexander, MD

  DHMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Radiology

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 23, 2021
• Study Start: March 17, 2022
• Primary Completion: July 3, 2023
• Study Completion: March 31, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)