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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000652-11 | EudraCT Number |
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This is a Phase IIa, open-label, non-randomised and non-placebo-controlled study. The study is designed to evaluate the diagnostic value and safety of a single intravenous dose of SN132D in up to 18 participants with suspected endometriosis. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose (i.v.) SN132D | Experimental | SN132D is a nanoparticle solution at 20 µmol Mn/kg dosage, administrated via intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SN132D | Drug | Manganese-based macromolecular MRI contrast agent |
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| Measure | Description | Time Frame |
|---|---|---|
| MRI enhancing effect | MRI enhancing effect will be evaluated by assessing changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences, analysing contrast-to-noise in endometriosis lesions vs reference tissue, signal-to-noise in endometriosis lesions. Additional MR-scan characteristic parameters may be calculated if deemed appropriate. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Value Evaluation for endometriosis lesions. | Compare the number, size and site of endometriosis lesions obtained by SN132D imaging to transvaginal ultrasound (TUS) and clinically used non-contrast MRI | Day 1 |
| Diagnostic Value Evaluation for deep pelvic endometriosis lesions. |
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Inclusion Criteria:
Signed informed consent including willingness to undertake 3 MRI investigations in one day.
Females with endometriosis or suspected endometrial lesions at transvaginal ultrasound examination.
At least 18 years of age when signing the informed consent.
Adequate renal and hepatic function:
eGFR ≥ 50 mL/min/1.73 m2, bilirubin <1 x upper limit of normal (ULN), creatinine <1 x ULN, ASAT and ALAT < 1 x ULN, Bilirubin ULN: 25 µmol/L, creatinine ULN: 90 µmol/L, ASAT ULN: 0.60 µkat/L and ALAT ULN: 0.75 µkat/L) at the screening visit.
Females of child-bearing potential* must agree to the use of effective contraception** or practice abstinence during the study and for 30 days after the IMP administration.
*A female of child-bearing potential is a sexually mature female who 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. had had menses at any time in the preceding 24 consecutive months).
**Effective contraception is defined as contraceptive methods with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]).
Adequate haematological function: haemoglobin (Hb) ≥90 g/L, absolute neutrophil count (ANC) ≥1.3x109 /L and platelet count ≥ 100 x 109 /L.
Exclusion Criteria:
Female participants with suspected endometrial lesions
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| Name | Affiliation | Role |
|---|---|---|
| Ligita Jokubkiene, MD, PhD | Senior Consultant Skåne University Hospital, Assoc Prof Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kvinnokliniken, Skåne University Hospital | Malmö | Skåne County | 20501 | Sweden |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Open-label, non-randomised and non-placebo-controlled study
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Compare the number, size and site of deep pelvic endometriosis lesionsobtained by SN132D imaging to transvaginal ultrasound (TUS) and clinically used non-contrast MRI |
| Day 1 |
| Number of treatments related adverse events (AEs) | Day 1 up to 2 weeks |
| D000091662 | Genital Diseases |