Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05022602
Eligibility Criteria:
Inclusion Criteria:
1. Has a signed and dated informed consent, prior to initiation of any study-related activities.
2. Is at least 18 years of age.
3. Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
4. Is willing and able to comply with protocol-required scans
Exclusion Criteria:
1. Is pregnant or lactating.
2. Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view.
3. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline.
4. Is currently undergoing phototherapy.
5. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
6. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
7. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
8. Currently has mastitis.
9. Prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05022602
Study Brief:
Protocol Section:
NCT05022602