Prospective Case Collection Study for New Mammography Technologies

• Sponsor: Hologic, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05199701
• Collaborator: (none)
• Enrollment: 5,400
• Locations: 12
• Arms: 2
• Anticipated Duration (Months): 47.7
• Patients Per Site: 450
• Patients Per Site Per Month: 9.4

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.

Condition or Disease	Intervention/Treatment	Phase
Mammography	Device: Mammography	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 5400 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Prospective Case Collection Study for New Mammography Technologies
• Actual Study Start Date: Dec 10, 2021
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Screening Subjects Screening Subjects	Device: Mammography; Hologic pre-market Mammography
Other: Subjects recommended for biopsy Subjects recommended for biopsy	Device: Mammography; Hologic pre-market Mammography

Outcome Measures

Primary Outcome Measures

1. Clinically acceptable image quality of the Investigational Device. [4 years]

   Questionnaire will be used to measure outcomes

2. Mammograms can be safety acquired on the Investigational Device. [4 years]

   Will be determined using the AE assessment.

Secondary Outcome Measures

1. The ease of positioning and usability of the Investigational Device. [4 years]

   Questionnaire will be used to measure outcomes

2. Subject assessment of comfort of the Investigational Device. [4 years]

   Questionnaire will be used to measure outcomes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject is female of any race and ethnicity

• Subject is at least 35 years old

• Subject is indicated for a screening mammogram or breast biopsy

Exclusion Criteria:

• Subject is pregnant or thinks she may be pregnant

• Subject is wheelchair bound and cannot stand independently

• Subject has breast implants, cardiac pacemakers or IV ports in the mammography field of view

• Subject previously participated in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Medical Imaging	Gilbert	Arizona	United States	85297
2	Diagnostic Centers of America Palm Beach Gardens	Palm Beach Gardens	Florida	United States	33410
3	Diagnostic Centers of America West Palm Beach	West Palm Beach	Florida	United States	33401
4	Baptist Health	Louisville	Kentucky	United States	40207
5	Progressive Radiology	Bel Air	Maryland	United States	21014
6	Spectrum Health	Grand Rapids	Michigan	United States	49503
7	Elizabeth Wendy Breast Care	Rochester	New York	United States	14620
8	Solis Mammography Greensboro	Greensboro	North Carolina	United States	27401
9	Solis Mammography Columbus	Columbus	Ohio	United States	43214
10	Solis Mammography Burleson	Burleson	Texas	United States	76028
11	Washington Radiology	Arlington	Virginia	United States	22201
12	Washington Radiology	Sterling	Virginia	United States	20166

Sponsors and Collaborators

• Hologic, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hologic, Inc.
• ClinicalTrials.gov Identifier: NCT05199701
• Other Study ID Numbers: 20-08
• First Posted: Jan 20, 2022
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jun 8, 2022