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A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02550210
Recruitment Status : Completed
First Posted : September 15, 2015
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center

Brief Summary:
In this study, the investigators will enroll women with palpable cancers to assess the accuracy of the Breast Cancer Locator (BCL) and the concomitant procedure as a vehicle to optimize and validate the approach in such surgical cases. This approach of adopting palpable cancer patients before initiating an evaluative trial of the BCL in non-palpable breast cancer cases ensures that the BCL does not substantially alter or modify the standard-of-care procedure.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Breast Cancer Locator (BCL) Not Applicable

Detailed Description:
The investigators propose to test whether the Breast Cancer Locator (BCL) accurately defines the edges of the tumor. Twenty patients with palpable invasive breast cancer will undergo preoperative supine MRI, the creation of a BCL, and breast-conserving surgery using the BCL as an adjunct to palpation-guided tumor resection. Participants will also have the tumor position on their skin localized with the supine MR/optical scan/tracker method. The primary objective is to measure the distance from the center of the spots made by the BCL to the cancer edges.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers
Study Start Date : August 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Breast Cancer Locator (BCL)
The Breast Cancer Locator (BCL) uses 3D printing to create a bra-like plastic form that matches the breast surface when the patient is in the supine MRI (and surgical) position. This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure.
Device: Breast Cancer Locator (BCL)
This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.




Primary Outcome Measures :
  1. The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins. [ Time Frame: 30 Days ]
    Five measurements will be made per patient and the mean difference in distance will be derived between the palpated and the co-registered supine MRI-optical scan image predicted tumor edges. The BCL will be considered accurate if all 5 measurements are > 0 cm from the tumor edge.


Secondary Outcome Measures :
  1. Positive Margin Rate [ Time Frame: 30 Days ]
    The positive margin rate as defined by standard pathologic evaluation of the entire specimen.

  2. The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System [ Time Frame: 30 days ]
    Distances will be measured and descriptive statistics will be employed.

  3. Mean Resection Specimen Volume [ Time Frame: 30 days from surgery ]
    Volumes will be measured and descriptive statistics will be employed. The specimen volume is determined by recording the water displacement and specimen scanning.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
  • Patient desire to undergo breast surgery
  • Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted
  • The cancer enhances on breast MRI imaging.

Exclusion Criteria:

  • Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
  • Severe claustrophobia
  • Contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine > 2.0)
  • History of median sternotomy
  • Pregnancy. Patient attestation that they are not pregnant will be acceptable as per standard policy for MRIs at DHMC.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550210


Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
  Study Documents (Full-Text)

Documents provided by Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center:

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Responsible Party: Richard J. Barth,Jr., MD, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02550210    
Other Study ID Numbers: D15120
First Posted: September 15, 2015    Key Record Dates
Results First Posted: April 30, 2019
Last Update Posted: April 30, 2019
Last Verified: April 2019
Keywords provided by Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center:
Breast Conserving Surgery
Breast Imaging
Breast Diagnostics
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases