Clinical Trials in the USA / NCT07086248
Active, not recruiting
Not applicable
A Study to Determine if RADIESSE® Dilute Treatment in Décolleté of Adult Women Affects Radiographic Imaging Assessments
NCT07086248 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Décolleté Wrinkles
Investigational drug(s) / intervention(s)
Radiesse
Radiesse: Radiesse injections diluted 1:2 with sterile saline.
Study summary
The primary purpose of this study is to determine if treatment with Radiesse dilute in the décolleté interferes with radiographic imaging of the breast tissue.
Eligibility
Inclusion Criteria:
* Participants seeking improvement of moderate to severe décolleté wrinkles.
* Participant is willing to undergo up to three bilateral mammograms and up to four bilateral ultrasound procedures.
Exclusion Criteria:
* Any pre-existing serious disease or disorder of the breast tissue that may confound interpretation of radiographic and/or ultrasound imaging (example., participants with a history of breast cancer or an immediate family history of breast cancer \[that is., mother, sister, and/or daughter\], pathogenic or likely pathogenic breast cancer (BRCA) gene variant, calcifications and/or microcalcifications detected on previous mammography \[up to three years prior to study start, if available\]).
* Present uncontrolled malignant disease.
* Any condition that would caution against receiving additional radiation exposure in the breasts.
* Any previous surgery, including plastic surgery or permanent surgical implant, or previous non-surgical treatment in the planned in the treatment area and in the breasts.
Primary outcome measure(s)
- Any Interference of Radiesse Dilute in Either Breast Observed in Breast Ultrasound or Mammogram Images at Week 17, As Assessed By an Adjudication Committee Composed of Two Board-certified Radiologists — Week 17
Interference is defined as a "Yes" response to questions (Q) Q2, Q3, Q5, or Q6 by at least one adjudication committee member. The questionnaire includes six questions assessing product visibility on breast imaging and its impact on diagnostic interpretation. For ultrasound: Q1 asks if the product is visible on the assessed breast ultrasound image(s) (Yes/No). If visible, Q2 asks if it inhibits accurate breast tissue assessment (Yes/No), and Q3 asks if it may cause a false positive leading to additional screening or unnecessary biopsies (Yes/No). For mammography: Q4 asks if the product is visible on the assessed mammogram image(s) (Yes/No). If visible, Q5 asks if it inhibits accurate breast tissue assessment (Yes/No), and Q6 asks if it may cause a false positive leading to further screening or unnecessary biopsies (Yes/No).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Merz Investigative Site | Alpharetta | Georgia |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07086248 on ClinicalTrials.gov ↗ ← All trials in the USA