Suspected endometriosis MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: SN132D
Product Code: SN132D
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: pegfosimer manganese
CAS Number: 2641234-28-6
Other descriptive name: SN132D
Concentration uni
Sponsors
Spago Nanomedical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, participants must fulfil the following criteria: 1. Signed informed consent including willingness to undertake 3 MRI investigations in one day 2. Females with endometriosis or suspected endometrial lesions at ultrasound examination 3. At least 18 years of age when signing the informed consent. 4. Adequate renal and hepatic function: eGFR = 50 mL/min/1.73 m2, bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants must not enter the study if any of the following exclusion criteria are fulfilled: 1. Female participants who are pregnant or who are currently breast feeding. 2. Conditions contraindicating MRI including, but not limited to, BMI > 40 kg/m2 at screening claustrophobia, metallic implants or internal electrical devices (e.g., cochlear implant, nerve stimulator, gastric pacemaker, bladder stimulator, pacemaker, defibrillator, artificial valves in heart, aneurysm clips, etc.), and permanent makeup or tattoos which in the Investigator's opinion might jeopardise the patient's safety or interfere with the imaging measurements. The Investigator is encouraged to contact the MR clinic for advice on which implants, tattoos, etc may be unsuitable. 3. Moderate to severe hypertension as judged by the Investigator. 4. History of significant cardiovascular disease such as myocardial infarction, congestive heart failure, stroke, serious cardiac arrhythmias, history of angina within 6 months prior to screening. 5. Clinically diagnosed obstruction of bile duct as judged by investigator. 6. Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) which, in the opinion of the Investigator is clinically relevant, or will interfere with the ECG analysis. 7. Abnormalities detected during examination at screening and admission, which in the opinion of the Investigator, may either put the patient at risk because of participation in the study or influence the results or the patient’s ability to participate in the study. 8. Active infection requiring systemic treatment within one week prior to agent administration. 9. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient’s ability to participate in the study. 10. 6. Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. Participants with chronic HBV or HCV infection are eligible at the investigator’s discretion provided that the disease is stable and sufficiently controlled under treatment.. 11. Any use of alcohol within 24 hours of admission to the clinic. 12. Plasma donation within 1 month of screening or any blood donation or corresponding blood loss during 3 months prior to screening. 13. Use of investigational agent within four weeks before Visit 1 or plans to initiate treatment with an investigational agent during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the MRI enhancing properties of SN132D in participants with suspected endometriosis;Secondary Objective: •To evaluate the diagnostic value of SN132D for detection of deep pelvic endometriosis lesions in participants with suspected endometriosis. •To evaluate the diagnostic value of SN132D for detection of endometriosis lesions in participants with suspected endometriosis. •To evaluate the safety of SN132D following single administration in participants with suspected endometriosis. ;Primary end point(s): MRI enhancing effect: •Changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences: oContrast-to-noise in endometriosis lesions vs reference tissue oSignal-to-noise in endometriosis lesions Additional MR-scan characteristic parameters may be calculated if deemed appropriate. ;Timepoint(s) of evaluation of this end point: Predose MRI will be done same day as dose is given or up to 10 days before the dose. Second MRI is done 1 hour after the end of infusion and third MRI 4 hours after the end of infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Diagnostic Value Evaluation for deep pelvic endometriosis lesions and endometriosis lesions: • Compare the number, size and site of deep pelvic endometriosis lesions/endometriosis lesions obtained by SN132D imaging to TUS and clinically used non-contrast MRI. Safety: • Frequency and severity of adverse events (AEs) • Clinically significant changes in: Electrocardiogram (ECG) Vital signs Safety laboratory parameters Physical examination findings • Frequency and severity of injection site reactions ;Timepoint(s) of evaluation of this end point: Diagnostic value: Pre-dose MRI: same day as dose or up to 10 days before the dose. MRI post SN132D administration: 1h and 4h after the end of infusion. TUS is done same day as dose or up to 10 days before the dose. Safety: • Frequency and severity of AEs: Throughout the study, from dose until follow up. ECG and Vital signs: At screening and regular intervals from pre-dose until 4 h after end of infusion Safety laboratory parameters: At screening, pre-dose, 4 h after end of infusion and at follow-up visit (3-14 days after the dose) Physical examination findings: At screening, pre- dose, 4 h after end of infusion and at follow-up visit (3-14 days after the dose) • Frequency and severity of injection site reactions: Throughout the study, from dose until follow up | — |
Countries
Sweden
Contacts
Public Contactpaul.hargreaves@spagonanomedical.se
Spago Nanomedical AB
Outcome results
None listed