Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:30 AM
Study NCT ID:
NCT07310758
Status:
RECRUITING
Last Update Posted:
2025-12-30
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast-enhanced Ultrasound for Sentinel Node Detection
Sponsor:
The Netherlands Cancer Institute
Organization:
Study Overview
Official Title:
Contrast-enhanced Ultrasound for Sentinel Node Detection in Patients With Melanoma, Breast Cancer or Head & Neck Cancer
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-center interventional non-inferiority study where subjects are participating for one day for patients 18 years or older with melanoma, breast cancer or head \& neck cancer (including melanoma of head and neck area) and scheduled for a surgical SN procedure in the NKI-AvL without any contra-indication for Sonazoid contrast agent, such as an allergy to eggs or egg products. The primary objective is to assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Secondary objectives are the specificity of CEUS for intra-operative SN localization, the time required to localize the SNs using CEUS and intraoperative usability of the CEUS-system. The primary endpoint is the sensitivity of the CEUS SN localization method. The conventional gamma probe will be used as ground truth comparison.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: