Clinical trial • Not applicable • Oncology

Perflubutane for Breast cancer | Melanoma | Head and neck cancer

Not applicable trial of Perflubutane for Breast cancer | Melanoma | Head and neck cancer. 91 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer | Melanoma | Head and neck cancer
Trial Stage
Not applicable
Drug Modality
Diagnostic agent

Key dates

Initial CTIS Submission Date
09-09-2024
First CTIS Authorization Date
09-12-2024

Trial design

Not applicable trial across 1 site in Netherlands.

Target Sample Size
91
Trial Duration For Participant
1

Eligibility

Recruits 91 No vulnerable population selected; participants must be adults (Aged 18 years or older). Written informed consent is required from the patient..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
No vulnerable population selected; participants must be adults (Aged 18 years or older). Written informed consent is required from the patient.

Inclusion criteria

  • {"criterion_text":"- Aged 18 years or older\n- Patient has been diagnosed with cancer in the skin (melanoma), breast or head & neck (including melanoma of head and neck area)\n- In case of a melanoma: it should be located in the limbs or head and neck area\n- Scheduled for a surgical SN procedure at the NKI-AvL\n- Patient provides written informed consent"}

Exclusion criteria

  • {"criterion_text":"- Pregnancy\n- Any known clinically significant acute hypersensitivity reaction to the study medication, such as eggs or egg products\n- Other contra-indications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary arterial disease and serious pulmonary disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- sensitivity and specificity of the CEUS SN localization method","definition_or_measurement_approach":"Assessed by comparing CEUS intra-operative sentinel node (SN) localization to the gold standard (99mTc nanocolloid) to calculate sensitivity and specificity."}

Secondary endpoints

  • {"endpoint_text":"- time required to localize the SNs using CEUS in minutes","definition_or_measurement_approach":"Measured in minutes required to localize sentinel nodes using CEUS."}
  • {"endpoint_text":"- usability of the CEUS system using a system-usability-score (SUS)","definition_or_measurement_approach":"Assessed using a system-usability-score (SUS) questionnaire for the CEUS system."}
  • {"endpoint_text":"- sensitivity and specificity of using CEUS to predict if SNs are malignant","definition_or_measurement_approach":"Calculated sensitivity and specificity of CEUS for predicting malignancy of sentinel nodes (comparison to reference standard/pathology)."}

Recruitment

Planned Sample Size
91
Recruitment Window Months
12
Consent Approach
Written informed consent required from the patient (adult participants aged ≥18). Subject information and informed consent form document available (L1_SIS and ICF N24CUS_redacted). A Dutch translation of trial materials is present.

Geography

Total Number Of Sites
1
Total Number Of Participants
91

Netherlands

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
09-12-2024
Processing Time Days
39
Number Of Sites
1
Number Of Participants
91

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Surgery
Principal Investigator Name
Quirijn Tummers
Principal Investigator Email
q.tummers@nki.nl
Contact Person Name
Quirijn Tummers
Contact Person Email
q.tummers@nki.nl
Number Of Participants
91

Sponsor

Primary sponsor

Full Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Sonazoid 8 mikroliter per ml pulver og væske til injeksjonsvæske, dispersjon
Active Substance
Perflubutane
Modality
Diagnostic agent
Routes Of Administration
Intratumoral use
Route
Intratumoral use
Authorisation Status
Authorised (marketing authorisation number 11-8225 in NO)
Dose Levels
Not specified; maximum total dose 6 ml
Maximum Dose
6 ml

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