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A Proof of Concept Study Concerning Efficacy of SN132D in Patients With Suspected Endometriosis

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
SN132D
Sponsored by
Spago Nanomedical AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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. 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.

Sites / Locations

  • Kvinnokliniken, Skåne University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single dose (i.v.) SN132D

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Number of treatments related adverse events (AEs)

Full Information

First Posted
December 7, 2022
Last Updated
December 25, 2022
Sponsor
Spago Nanomedical AB
Collaborators
Antaros Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05664828
Brief Title
A Proof of Concept Study Concerning Efficacy of SN132D in Patients With Suspected Endometriosis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spago Nanomedical AB
Collaborators
Antaros Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label, non-randomised and non-placebo-controlled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single dose (i.v.) SN132D
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SN132D
Other Intervention Name(s)
SpagoPix
Intervention Description
Novel manganese-based macromolecular MRI contrast agent
Primary Outcome Measure Information:
Title
MRI enhancing effect
Description
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 Outcome Measure Information:
Title
Diagnostic Value Evaluation for endometriosis lesions.
Description
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
Title
Diagnostic Value Evaluation for deep pelvic endometriosis lesions.
Description
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
Title
Number of treatments related adverse events (AEs)
Time Frame
Day 1 up to 2 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female participants with suspected endometrial lesions
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Development Officer
Phone
+46 46 81188
Email
info@spagonanomedical.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ligita Jokubkiene, MD, PhD
Organizational Affiliation
Seniour Consultant Skåne University Hospital, Assoc Prof Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kvinnokliniken, Skåne University Hospital
City
Malmö
State/Province
Skåne
ZIP/Postal Code
20501
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ligita Jokubkiene, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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A Proof of Concept Study Concerning Efficacy of SN132D in Patients With Suspected Endometriosis

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