EndometriosisPhase 2NCT05664828
Efficacy of SN132D in Patients With Suspected Endometriosis
A Phase 2 study testing SN132D in people with Endometriosis, run by Spago Nanomedical AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- SN132D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 17 Nov 2022to 12 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Female participants who are pregnant or who are currently breast feeding.
- 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.
- Moderate to severe hypertension as judged by the Investigator.
- 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.
- Clinically diagnosed obstruction of bile duct as judged by the Investigator.
- 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.
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- 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.
- Active infection requiring systemic treatment within one week prior to agent administration.
- 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.
- 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.
- Any use of alcohol within 24 hours of admission to the clinic.
- Plasma donation within 1 month of screening or any blood donation or corresponding blood loss during 3 months prior to screening.
- Use of investigational agent within four weeks before Visit 1 or plans to initiate treatment with an investigational agent during the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Kvinnokliniken, Skåne University Hospital
Malmö, Skåne County, 20501
About this study
Official title: A Phase IIa, Single Centre, Open Label, Proof of Concept Study Concerning Efficacy of the Novel Intravenous Contrast Agent SN132D in Patients With Suspected Endometriosis.
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.
- Conditions
- Endometriosis
- Being tested
- SN132D
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SN132DDrug
Also called SpagoPix
Manganese-based macromolecular MRI contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Single dose (i.v.) SN132D | Experimental | SN132D is a nanoparticle solution at 20 µmol Mn/kg dosage, administrated via intravenous infusion. Receives: Drug: SN132D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
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
Measured: 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
Measured: Day 1
Number of treatments related adverse events (AEs)
Measured: Day 1 up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start17 Nov 2022
- Primary completion20 Jun 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, non-randomised and non-placebo-controlled study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spago Nanomedical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ligita Jokubkiene, MD, PhD, Principal investigator, Senior Consultant Skåne University Hospital, Assoc Prof Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664828
- Sponsor's protocol ID
- SPAGOPIX-02
- Other IDs
- 2022-000652-11
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Single Centre, Open Label, Proof of Concept Study Concerning Efficacy of the Novel Intravenous Contrast Agent SN132D in Patients With Suspected Endometriosis.
- ClinicalTrials.gov ID
- NCT05664828
- Acronym / sponsor ID
- SPAGOPIX-02
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Spago Nanomedical ABIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, non-randomised and non-placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Single dose (i.v.) SN132D | Experimental | Drug: SN132DSN132D is a nanoparticle solution at 20 µmol Mn/kg dosage, administrated via intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- Female participants who are pregnant or who are currently breast feeding.
- 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.
- Moderate to severe hypertension as judged by the Investigator.
- 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.
- Clinically diagnosed obstruction of bile duct as judged by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SN132DAlso: SpagoPixManganese-based macromolecular MRI contrast agent | Drug | Single dose (i.v.) SN132D |
Primary outcome
MRI enhancing effect
Time frame: Day 1
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.
3 secondary outcomes
Diagnostic Value Evaluation for endometriosis lesions.
Time frame: Day 1
Diagnostic Value Evaluation for deep pelvic endometriosis lesions.
Time frame: Day 1
Number of treatments related adverse events (AEs)
Time frame: Day 1 up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligita Jokubkiene, MD, PhD principal investigator
Senior Consultant Skåne University Hospital, Assoc Prof Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SN132D in people with Endometriosis, run by Spago Nanomedical AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI enhancing effect (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.