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CompletedNCT05664828Updated Dec 12, 2023

Efficacy of SN132D in Patients With Suspected Endometriosis

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

Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study summary

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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Conditions studied

  • Endometriosis

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03

In context

Endometriosis

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 →

Lead sponsor

Spago Nanomedical AB is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed informed consent including willingness to undertake 3 MRI investigations in one day.
  2. Females with endometriosis or suspected endometrial lesions at transvaginal 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 \<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.

  5. 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]).

  6. Adequate haematological function: haemoglobin (Hb) ≥90 g/L, absolute neutrophil count (ANC) ≥1.3x109 /L and platelet count ≥ 100 x 109 /L.

Exclusion criteria

Exclusion Criteria:

  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 the 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. 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.
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Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Single dose (i.v.) SN132D

    SN132D is a nanoparticle solution at 20 µmol Mn/kg dosage, administrated via intravenous infusion.

    Drug: SN132D

Interventions

  • DrugSN132D

    Manganese-based macromolecular MRI contrast agent

    Also known as: SpagoPix

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  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

  2. 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

  3. Number of treatments related adverse events (AEs)

    Time frame: Day 1 up to 2 weeks

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Study locations

1 site
  • Kvinnokliniken, Skåne University Hospital
    Malmö, Skåne County 20501, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05664828
Lead sponsor
Spago Nanomedical AB
Responsible party
Sponsor
First posted
Dec 27, 2022
Start date
Nov 17, 2022
Primary completion
Jun 20, 2023
Completion
Sep 12, 2023
Last update
Dec 12, 2023

Study contacts

Ligita Jokubkiene, MD, PhD
principal investigator · Senior Consultant Skåne University Hospital, Assoc Prof Lund University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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