Health TrialsbyHealthPanel

Contrast-enhanced Ultrasound for Sentinel Node Detection

ConditionsMelanomaBreast CancerHead & Neck Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older

Patient has been diagnosed with cancer in the skin (melanoma), breast or head & neck (including melanoma of head and neck area)

In case of a melanoma: it should be located in the limbs or head and neck area

Scheduled for a surgical SN procedure at the NKI-AvL

Disqualifiers

Pregnancy

Any known clinically significant acute hypersensitivity reaction to the study medication, such as eggs or egg products

Other contra-indications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary arterial disease and serious pulmonary disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Sonazoid

    Drug

    Intradermal injection of the ultrasound contrast agent Sonazoid.

Treatment groups

91 Participants
are divided into 1 treatment group
Group A: Intra-operative Sonazoid injectionOther 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of the CEUS SN localization method

To assess the sensitivity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid). Could CEUS replace the conventional radioactive technetium method?

Time frame
1 day

Secondary outcomes

1

Specificity of the CEUS SN localization method

Specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid)

Time frame
1 day
2

Time in minutes

Time required to localize the SNs using CEUS.

Time frame
1 day
3

System-usability score (SUS) and questionnaire for the surgeon.

Intraoperative usability of the CEUS-system.

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Netherlands Cancer Institute

Lead sponsor

GE Healthcare

Collaborator

Source ClinicalTrials.gov
Apply now