Clinical Trial Results:
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.
Summary
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EudraCT number |
2022-000652-11 |
Trial protocol |
SE |
Global end of trial date |
20 Jun 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jun 2024
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First version publication date |
30 Jun 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SPAGOPIX-02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05664828 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Spago Nanomedical AB
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Sponsor organisation address |
Scheelevagen 22, Lund, Sweden,
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Public contact |
mats.hansen@spagonanomedical.se, Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se
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Scientific contact |
mats.hansen@spagonanomedical.se, Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Oct 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Jun 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Jun 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
• To evaluate the MRI enhancing properties of SN132D in participants with suspected endometriosis
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Protection of trial subjects |
GDPR followed. GCP Followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Dec 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Sweden: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
8
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
8
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were prescreened with TUS | ||||||
Pre-assignment
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Screening details |
Patients with suspected endometriosis | ||||||
Period 1
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Period 1 title |
Active infusion baseline (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
N/A
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Arms
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Arm title
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SN132D | ||||||
Arm description |
Dose of 20 µmol Mn/kg | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
SN132D
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
SN132D was administered as a 1-hour single i.v. infusion using a syringe pump with a saline carrier. Participants received a single i.v. infusion of SN132D at a dose of 20 µmol Mn/kg.
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Baseline characteristics reporting groups
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Reporting group title |
Active infusion baseline
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
SN132D
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Reporting group description |
Dose of 20 µmol Mn/kg | ||
Subject analysis set title |
MRI analysis set - baseline values
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The MRI analysis set consisted of all participants who received the IMP and for whom at least the predose MRI scan and 1 post-dose MRI scan had been performed. Results for individual participants at baseline.
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Subject analysis set title |
1h after end of MRI infusion
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants in the magnetic resonance imaging (MRI) analysis set who received the SND132D infusion 1 hour after the end of the SN132D infusion
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Subject analysis set title |
4h after end of MRI infusion
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants in the magnetic resonance imaging (MRI) analysis set who received the SND132D infusion 4 hours after the end of the SN132D infusion
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Subject analysis set title |
TUS analysis set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants in the magnetic resonance imaging (MRI) analysis set whose endometriosis lesions were evaluated at baseline by transvaginal ultrasound
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End point title |
Contrast-to-noise ratio in endometriosis lesions vs endometrium reference tissue [1] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
This primary endpoint covered the primary objective of evaluating the MRI enhancing properties of SN132D in participants with suspected endometriosis. The MRI enhancing effect was assessed by evaluating changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences.
Following the baseline MRI scan, study participants received a single dose of SN132D, administered as an intravenous infusion over 1 hour. Post-dose MRI scans were performed twice, at 1 hour and 4 hours after the end of the infusion. The contrast-to-noise ratio in endometriosis lesions was compared to that of reference tissue in a) endometrium (prespecified reference tissue) and b) skeletal muscle (post hoc reference tissue).
Note for lesion 9, no MRI scan was performed 4h after the end of the infusion for this participant.
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End point type |
Primary
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End point timeframe |
From baseline (pre-dose) to 4 hours after the end of the infusion. Magnetic resonance imaging (MRI) scans were performed at baseline (0h) and at 1h and 4h post-infusion.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was performed - imaging endpoints were presented using standard descriptive statistics for baseline and post-dose scans for individual participants. |
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No statistical analyses for this end point |
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End point title |
Signal-to-noise ratio in endometriosis lesions [2] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
This primary endpoint covered the primary objective of evaluating the MRI enhancing properties of SN132D in participants with suspected endometriosis. The MRI enhancing effect was assessed by evaluating changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences.
Following the baseline MRI scan, study participants received a single dose of SN132D, administered as an intravenous infusion over 1 hour. Post-dose MRI scans were performed twice, at 1 hour and 4 hours after the end of the infusion. The signal-to-noise ratio in endometriosis lesions was compared to that of reference tissue.
Note for lesion 9, no MRI scan was performed 4h after the end of the infusion for this participant.
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End point type |
Primary
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End point timeframe |
From baseline (pre-dose) to 4 hours after the end of the infusion. Magnetic resonance imaging (MRI) scans were performed at baseline (0h) and at 1h and 4h post-infusion.
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was performed - imaging endpoints were presented using standard descriptive statistics for baseline and post-dose scans for individual participants. |
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No statistical analyses for this end point |
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End point title |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Addresses the secondary objective of evaluating the diagnostic value of SN132D for detection of deep pelvic endometriosis lesions/endometriosis lesions in participants with suspected endometriosis. Following the baseline MRI scan, study participants received a single dose of SN132D by intravenous infusion over 1 hour. Post-dose MRI scans were performed twice, at 1 and 4 hours after the end of the infusion. Endometriosis lesions were measured and classified using the Enzian 2021 classification, a non-invasive and surgical description system for endometriosis. The diagnostic value of SN132D was evaluated by comparing the number, size and site of lesions obtained by SN132D imaging to transvaginal ultrasound and clinically used non-contrast MRI (observed at baseline, 0 h).
P=peritoneum. O=ovary. T=tube. A=vagina/rectovaginal space. B=uterosacral ligaments/cardinal ligaments/pelvic sidewall. C=rectum. F=far location (uterine and other extragenital locations).
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End point type |
Secondary
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End point timeframe |
From baseline (pre-dose) to 4 hours after the end of the infusion. MRI scans were performed at baseline (0h) and at 1h and 4h post-infusion.
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No statistical analyses for this end point |
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End point title |
Contrast-to-noise ratio in endometriosis lesions vs skeletal muscle reference tissue | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
This endpoint covered the primary objective of evaluating the MRI enhancing properties of SN132D in participants with suspected endometriosis. The MRI enhancing effect was assessed by evaluating changes between pre-dose images and post-dose images acquired using longitudinal relaxation time (T1)-weighted imaging sequences.
Following the baseline MRI scan, study participants received a single dose of SN132D, administered as an intravenous infusion over 1 hour. Post-dose MRI scans were performed twice, at 1 hour and 4 hours after the end of the infusion. The contrast-to-noise ratio in endometriosis lesions was compared to that of reference tissue in a) endometrium (prespecified) and b) skeletal muscle (post hoc reference tissue).
Note for lesion 9, no MRI scan was performed 4h after the end of the infusion for this participant.
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End point type |
Post-hoc
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End point timeframe |
From baseline (pre-dose) to 4 hours after the end of the infusion. Magnetic resonance imaging (MRI) scans were performed at baseline (0h) and at 1h and 4h post-infusion.
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
All adverse events (AEs, including serious AEs) were collected from the start of IMP administration on day 1 (visit 2) until the follow-up visit (visit 3) on day 3-14.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.1
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Reporting groups
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Reporting group title |
Full analysis set (FAS)
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Reporting group description |
The FAS consisted of all participants who received at least 1 dose of IMP. This population was used as the safety analysis set. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |