A Phase 2 interventional study of SN132D in Endometriosis, sponsored by Spago Nanomedical AB. Completed at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Spago Nanomedical AB · Phase 2, Interventional, and Diagnostic
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.
925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.
This study's enrollment of 8 is below the median of 65 across 539 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Spago Nanomedical AB is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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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]).
Exclusion Criteria:
SN132D is a nanoparticle solution at 20 µmol Mn/kg dosage, administrated via intravenous infusion.
Drug: SN132D
Manganese-based macromolecular MRI contrast agent
Also known as: SpagoPix
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.
Time frame: Day 1
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
Time frame: Day 1
Diagnostic Value Evaluation for deep pelvic endometriosis lesions.
Compare the number, size and site of deep pelvic endometriosis lesionsobtained by SN132D imaging to transvaginal ultrasound (TUS) and clinically used non-contrast MRI
Time frame: Day 1
Number of treatments related adverse events (AEs)
Time frame: Day 1 up to 2 weeks
Plan to share: No
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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