PERFLUTREN for Indeterminate kidney lesions

Inclusion criteria

• {"criterion_text":"- Subject provides written informed consent and is willing to comply with protocol requirements.\n- Subject is at least 18 years of age\n- Subject is in good health determined by no clinically significant findings from medical history, physical examination, clinical laboratory data, vital sign measurements and the 12-lead ECG"}

Exclusion criteria

• {"criterion_text":"- Subject is older than 50 years of age, as below the age of 50 there is the least risk of subjects having underlying (kidney) problems or other comorbidities\n- Subject is receiving any other contrast medium, within 48hours before and up to 24 hours following the administration of HarMono-T\n- Subject has any known allergy to one or more of the ingredients of the investigational product (per-flutren (C3F8) gas or to any other components of HarMono-T)\n- Subject has any contraindication to the planned imaging procedure (ultrasound) e.g., implants, inadequate medical conditions etc\n- Subject has received an investigational compound within 30days before admission into this study\n- Subject has any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objec-tives, or completing the study and/or post-dose follow-up examinations\n- Subject is determined by the Investigator that the subject is clinically unsuitable for the study\n- Subject is a pregnant or lactating female. Exclude the possibility of pregnancy by: o Testing on site at the institution with a rapid pregnancy test within 24 hours prior to the start of HarMono-T administration, o Surgical history (e.g., tubal ligation or hysterectomy), o Post-menopausal with a minimum one year without menses. o Peri-Menopausal (menopausal for less than 1 year)"}

Primary endpoints

• {"endpoint_text":"- The occurrence of adverse reactions until 7±2days post injection\n- 12-lead ECG\n- Vital signs\n- Clinical laboratory parameters (haematology; renal and hepatic functions)","definition_or_measurement_approach":"- Occurrence of adverse reactions monitored up to 7±2 days after injection (safety monitoring window).\n- 12-lead ECG performed to assess cardiac safety (measurement approach not further specified).\n- Vital signs measured (specific parameters and timing not further specified).\n- Clinical laboratory parameters include haematology and renal and hepatic function tests (specific panels/timing not further specified)."}

Secondary endpoints

• {"endpoint_text":"- Parametric imaging (Time to Peak (s), Peak Enhance-ment (dB))\n- Parametric imaging (Wash-in Area Under the Curve (dB), Wash-out Area Under the Curve (dB))\n- Parametric imaging (Peak Enhancement (dB))\n- CEUS at 30minutes post dose is to confirm total clearing of HarMono-T","definition_or_measurement_approach":"- Parametric imaging endpoints measured by CEUS: Time to Peak (seconds) and Peak Enhancement (dB) (specific imaging protocols not provided).\n- Wash-in and Wash-out AUC measured in dB using parametric imaging (specific analysis methodology not provided).\n- Peak Enhancement (dB) as measured by parametric CEUS imaging (methodology not specified).\n- Contrast-enhanced ultrasound (CEUS) at 30 minutes post dose to confirm total clearing of HarMono-T."}

Germany

Earliest CTIS Part Ii Submission Date

17-07-2025

Latest Decision Or Authorization Date

12-08-2025

Processing Time Days

26

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Solstice Pharmaceuticals B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands