Healthy VolunteersPhase 2NCT06693375
To Evaluate Dose and Safety of NanoEcho Particle-1 Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers and Rectal Cancer Patients.
A Phase 2 study testing Iron oxide nanoparticles and Rectal Magnetomotoric ultrasound (MMUS) in people with Healthy Volunteers and Rectal Cancer Patients, run by NanoEcho AB at 1 site in Sweden.
Trial summary
Clinical nodal staging for rectal cancer tumours in early stages, is today shown to be unreliable and no precise or accurate methods exist. Thus, there is an unmet need for better clinical staging of rectal cancer in early stages. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Rectal Cancer Patients
- What is being tested?
- Iron oxide nanoparticles and Rectal Magnetomotoric ultrasound (MMUS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 29 Oct 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A
- Willing and able to give written informed consent for participation in the trial.
- Healthy male participant, or female participant of non-childbearing potential aged 18 to 50 years, inclusive.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator. (Discussion is encouraged between the Investigator and the Sponsor Medical Representative regarding the clinical relevance of any abnormal laboratory value during the pre dose period).
- Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] >25 IU/L is confirmatory).
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- Male participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the administration of IMP until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of childbearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above) from at least 2 weeks prior to the administration of IMP to 4 weeks after the administration of IMP.
- Part B
- Willing and able to give written informed consent for participation in the trial aged 18 to 99 years, inclusive.
- Participant with primary rectal cancer planned for surgery with suspected spread to lymph nodes. No suspicion of systemic tumour spread. MRI must have been performed within the last 3 months before administration of IMP.
- Diagnosed with clinical stage T1-T4.
- It should be possible to use a probe in rectum (no tumour that blocks).
- Male participant, or female participant of non-childbearing potential ≥ 18 years of age.
- Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of FSH >25 IU/L is confirmatory).
- Male participants must be willing to use condom or be vasectomised or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the administration of IMP until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of childbearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above) from at least 2 weeks prior to the administration of IMP to 4 weeks after the administration of IMP.
Who cannot join
- Part A
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- Any previous or current anorectal disorder which may increase risk or burden of trial participation.
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- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
- After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: <90 or ≥140 mmHg, or - Diastolic blood pressure <50 or ≥90 mmHg, or - Pulse <40 or ≥90 bpm
- Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to the IMP, IMP excipients or other parenteral iron products, or excipients of the enema to be used in the trial.
- Person with pacemaker.
- Person with metal implants.
- Previous history of full radiation of rectum.
- Regular use of any prescribed or non-prescribed medications, including antacids, analgesics, herbal remedies, vitamins and minerals, within 2 weeks prior to the (first) administration of IMP, except occasional intake of paracetamol (maximum 2000 mg/day and not exceeding 3000 mg/week), as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Participants consented and screened but not dosed in previous phase I trials are not to be excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times/week is allowed before the screening visit.
- Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the trial site prior to the (first) administration of the IMP. (Positive results that are expected given the participant's medical history and prescribed medications can be disregarded as judged by the Investigator.)
- History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- History of, or current use of anabolic steroids, as judged by the Investigator.
- The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
- Part B History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- 2. Person with any kind of stoma. 3. Person with pacemaker. 4. Person with metal implants. 5. Previous history of radiation of rectum. 6. Prescence of malignancy other than rectal cancer. 7. After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: <90 or ≥140 mmHg, or - Diastolic blood pressure <50 or ≥90 mmHg, or - Pulse <40 or ≥90 bpm 8. Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
- 9. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to the IMP, IMP excipients or other parenteral iron products.
- 10. Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Participants consented and screened but not dosed in previous phase I trials are not to be excluded.
- 11. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Clinical Trial Consultants
Uppsala, 75237
Erik Principle Investigator, +46707552089, erik.rein-hedin@ctc-ab.se
About this study
Official title: A Phase 2a, Exploratory, Two-Part, Open-Label Trial to Evaluate Dose and Safety of NanoEcho Particle-1 (Ferumoxtran) Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers, Part A, and Rectal Cancer Patients, Part B.
Clinical nodal staging for rectal cancer tumours in early stages, is today shown to be unreliable and no precise or accurate methods exist. Thus, there is an unmet need for better clinical staging of rectal cancer in early stages. If new imaging techniques for clinical staging of early rectal cancer are developed an opportunity for increased treatment by local excision and decreased unnecessary radical surgery would be possible.
NanoEcho Particle-1 (NEP-1, Ferumoxtran Lyophilisate 20 mg Fe/mL) will be used, in combination with NanoEcho Imaging Device, to enhance the signal in the detection and identification of possible spread of rectal cancer to nearby rectal regional lymph nodes by magnetomotive ultrasound (MMUS) technology.
Read more
NEP-1 is an ultrasmall superparamagnetic iron oxide (USPIO)-based contrast agent. It belongs to the specific contrast agents-group, which are specific to reticuloendothelial system (liver, spleen, lymph nodes, bone marrow), mainly represented by iron oxide nanoparticles coated with macromolecules such as dextran in the presence of adjuvants (mineral salts, polyhydric alcohols, etc.). It belongs to the USPIO sub-group (with a mean particle diameter of 30 nm.
The NanoEcho Imaging Device is based on the MMUS technology. It aims to identify possible spread of rectal cancer to nearby rectal regional lymph nodes by visualisation of the movement, generated by the nanoparticles (nTrace).
The iron oxide-based nanoparticles, NEP-1, are administered submucosally at four separate administration sites locally in rectum, close to the suspected tumour area. After some time allowing the particles to spread, the MMUS probe, dressed in a probe cover with ultrasound gel inside, is inserted into the rectum. The nanoparticles are set in motion by a magnetic field, introduced by a rotating magnet located inside the probe. The motion of the tissue, the so-called tissue displacement, is detected with ultrasound and called NanoEcho visualisation of the movement generated by the nanoparticles (nTrace) and is visualised on the screen of the NanoEcho Imaging Device. The higher the concentration of the nanoparticles, the stronger the nTrace signal. Based on the distribution pattern of the particles, the system aims to support the user in distinguishing between healthy and metastatic lymph nodes located nearby the tumour within the rectal region.
Part A In Part A (healthy volunteers) of the trial, NEP-1 will be administered on a single occasion, followed by four MMUS-assessments, in four ascending dose groups of three participants each.
Part B In Part B (rectal cancer patients) of the trial, NEP-1 will be administered on a single occasion, followed by a MMUS assessment in a maximum of ten patients with rectal cancer. The dose level of NanoEcho Particle-1 (Ferumoxtran) to be used and the timepoint for the MMUS assessment will be decided based on Part A.
- Conditions
- Healthy Volunteers, Rectal Cancer Patients
- Being tested
- Iron oxide nanoparticles, Rectal Magnetomotoric ultrasound (MMUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron oxide nanoparticlesDrug
Also called contrast agent
Submucosal injection of nanoparticles in rectum, 28 mg Fe (7 mg Fe/mL)
Rectal Magnetomotoric ultrasound (MMUS)Device
MMUS examination of lymphnodes in rectum
Iron oxide nanoparticlesDrug
Also called Contrast agent
Submucosal injection in rectum 56 mg Fe (3,5 mg Fe/mL)
Iron oxide nanoparticlesDrug
Also called contrast agent
Submucosal injection in rectum : 56 mg Fe (14 mg Fe/mL)
Iron oxide nanoparticlesDrug
Also called contrast agent
Submucosal injection in rectum 112 mg Fe (14 mg Fe/mL)
| Study group | Role | What they receive |
|---|---|---|
| Dosing of IMP followed by MMUS evaluation | Experimental | In Part A, Each condition will be evaluated with MMUS after 7hours, 24hours 48hours and 72hours. The following conditions will apply:
Condition 1: Dose 1: 28 mg Fe (7 mg Fe/mL) Condition 2: Dose 2: 56 mg Fe (3,5 mg Fe/mL) Condition 3: Dose 2: 56 mg Fe (14 mg Fe/mL) Condition 4: Dose 3: 112 mg Fe (14 mg Fe/mL) In Part B, the dose level to be applied as well as the timepoint from MMUS evaluation, will be decided based on the outcome of Part A. Receives: Drug: Iron oxide nanoparticles; Device: Rectal Magnetomotoric ultrasound (MMUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Normalised average nTrace value for all lymph nodes at all timepoints
Dose-response curve and Time-response curve for normalised average nTrace value. nTrace value is NanoEcho visualisation of the movement generated by the nanoparticles
Measured: From dosing and up to 72 hours.
Part B, Normalised average nTrace value for all lymph nodes
Measured: From dosing to end of MMUS examination up to 72 hours
Secondary outcomes (16)
Part A. Size of lymph nodes with and without detectable nTrace in Healthy Volunteers
At what size of lymph nodes is (i) lymph nodes detectable (B mode) but no nTrace detectable in lymph nodes? (ii) nTrace detectable in lymph nodes? (iii) nTrace showing an even distribution in lymph nodes?
Measured: From dosing and up to 72 hours after dosing
Part A, Frequency, seriousness, and intensity of adverse events (AEs) for the IMP and the medical device.
Measured: From dosing until end of study Day 8 after dosing
Part A. User experience
Result of user experience questionnaire
Measured: From dosing up to 72 hours
Part B. Number of lymph nodes detected by NanoEcho diagnostic method compared to historic MRI data per section and overall
Measured: After the MMUS examination up to 72 hours after dosing
Part B, True positive fraction (N+) (sensitivity) and true negative fraction (N0) (specificity) of identified lymph node per section of rectum.
Measured: At end of MMUS examination up to 72 hours after dosing
Part A. Distance from injection to lymphnodes with and without detectable nTrace
At what distance from the injection is (i) lymph nodes detectable (B mode) but no nTrace detectable in lymph nodes? (ii) is nTrace detectable in lymph nodes? (iii) is nTrace showing an even distribution in lymph nodes?
Measured: From dosing and up to 72 hours after dosing
Part B. Size of lymph nodes with and without detectable nTrace in Rectal Cancer patients
At what size of lymph nodes is (i) lymph nodes detectable (B mode) but no nTrace detectable in lymph nodes? (ii) is nTrace detectable in lymph nodes? (iii) is nTrace showing an even distribution in lymph nodes?
Measured: From dosing and up to 72 hours after dosing
Part B, Frequency, seriousness, and intensity of adverse events (AEs) for the IMP and the medical device.
Measured: From dosing until end of study Day 8 after dosing
Part B. User experience
Result of user experience questionnaire
Measured: From dosing up to 72 hours
Part B. Distance from injection to lymph nodes with and without detectable nTrace in Rectal Cancer Patients
At what distance from the injection is (i) lymph nodes detectable (B mode) but no nTrace detectable in lymph nodes? (ii) is nTrace detectable in lymph nodes? (iii) is nTrace showing an even distribution in lymph nodes?
Measured: From dosing and up to 72 hours after dosing
Part B, Size of detectable metastases
Measured: End of MMUS examination up to 72 hours after dosing
Part B, distance form tumour to detectable tumour infiltration
Measured: End of MMUS examination up to 72 hours after dosing
Part A, Frequency and nature of device deficiencies (DDs).
Measured: From dosing until end of last examination after 72 hours
Part A, Safety and Tolerability of NEP 1 and NanoEcho Imaging Device examination in healthy volunteers.
Clinically significant changes in vital signs, ECG, safety laboratory measurements (haematology, clinical chemistry, coagulation) and physical examination findings.
Measured: From dosing until end of study Day 8 after dosing
Part B, Frequency and nature of device deficiencies (DDs).
Measured: From dosing until end of last MMUS examination after 72 hours after dosing
Part B, Safety and Tolerability of NEP 1 and NanoEcho Imaging Device examination in Rectal Cancer Patients
Clinically significant changes in vital signs, ECG, safety laboratory measurements (haematology, clinical chemistry, coagulation) and physical examination findings.
Measured: From dosing until end of study Day 8 after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start29 Oct 2024
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Part A: In total 12 healthy male participants, or healthy female participants of non-childbearing potential, aged 18 to 50 years (inclusive), with a body mass index (BMI) of 18.5 to 30.0 kg/m2 will be considered for trial participation. Part B: Male participants, or female participants of non-childbearing potential, aged \>18 years with primary rectal cancer (clinical stage T1-T4) planned for surgery with suspected spread to lymph nodes will be considered for trial participation. In Part A, the following dose levels will apply. Each participant will be in one condition. Each condition will be examined by MMUS at 7hours, 24hours, 48hours \&72hours post dose: * Condition1: Dose 1: 28 mg Fe (7 mg Fe/mL, 4 ml in total ) * Condition2: Dose 2: 56 mg Fe (3,5 mg Fe/mL, 16 mL in total) * Condition3: Dose 2: 56 mg Fe (14 mg Fe/mL, 4 mL in total) * Condition4: Dose 3: 112 mg Fe (14 mg Fe/mL, 8 mL in total) In Part B, the dose level to be applied will be decided based on the outcome of Part A.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NanoEcho AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693375
- Sponsor's protocol ID
- NEIS001
- Other IDs
- 2024-515335-29-00
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlies results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Exploratory, Two-Part, Open-Label Trial to Evaluate Dose and Safety of NanoEcho Particle-1 (Ferumoxtran) Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers, Part A, and Rectal Cancer Patients, Part B.
- ClinicalTrials.gov ID
- NCT06693375
- Acronym / sponsor ID
- NEIS001
- Conditions
- Healthy Volunteers, Rectal Cancer Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- NanoEcho ABIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Nov 2024 (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.
Clinical nodal staging for rectal cancer tumours in early stages, is today shown to be unreliable and no precise or accurate methods exist. Thus, there is an unmet need for better clinical staging of rectal cancer in early stages. If new imaging techniques for clinical staging of early rectal cancer are developed an opportunity for increased treatment by local excision and decreased unnecessary radical surgery would be possible.
NanoEcho Particle-1 (NEP-1, Ferumoxtran Lyophilisate 20 mg Fe/mL) will be used, in combination with NanoEcho Imaging Device, to enhance the signal in the detection and identification of possible spread of rectal cancer to nearby rectal regional lymph nodes by magnetomotive ultrasound (MMUS) technology.
NEP-1 is an ultrasmall superparamagnetic iron oxide (USPIO)-based contrast agent. It belongs to the specific contrast agents-group, which are specific to reticuloendothelial system (liver, spleen, lymph nodes, bone marrow), mainly represented by iron oxide nanoparticles coated with macromolecules such as dextran in the presence of adjuvants (mineral salts, polyhydric alcohols, etc.). It belongs to the USPIO sub-group (with a mean particle diameter of 30 nm.
The NanoEcho Imaging Device is based on the MMUS technology. It aims to identify possible spread of rectal cancer to nearby rectal regional lymph nodes by visualisation of the movement, generated by the nanoparticles (nTrace).
The iron oxide-based nanoparticles, NEP-1, are administered submucosally at four separate administration sites locally in rectum, close to the suspected tumour area. After some time allowing the particles to spread, the MMUS probe, dressed in a probe cover with ultrasound gel inside, is inserted into the rectum. The nanoparticles are set in motion by a magnetic field, introduced by a rotating magnet located inside the probe. The motion of the tissue, the so-called tissue displacement, is detected with ultrasound and called NanoEcho visualisation of the movement generated by the nanoparticles (nTrace) and is visualised on the screen of the NanoEcho Imaging Device. The higher the concentration of the nanoparticles, the stronger the nTrace signal. Based on the distribution pattern of the particles, the system aims to support the user in distinguishing between healthy and metastatic lymph nodes located nearby the tumour within the rectal region.
Part A In Part A (healthy volunteers) of the trial, NEP-1 will be administered on a single occasion, followed by four MMUS-assessments, in four ascending dose groups of three participants each.
Part B In Part B (rectal cancer patients) of the trial, NEP-1 will be administered on a single occasion, followed by a MMUS assessment in a maximum of ten patients with rectal cancer. The dose level of NanoEcho Particle-1 (Ferumoxtran) to be used and the timepoint for the MMUS assessment will be decided based on Part A.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part A: In total 12 healthy male participants, or healthy female participants of non-childbearing potential, aged 18 to 50 years (inclusive), with a body mass index (BMI) of 18.5 to 30.0 kg/m2 will be considered for trial participation. Part B: Male participants, or female participants of non-childbearing potential, aged >18 years with primary rectal cancer (clinical stage T1-T4) planned for surgery with suspected spread to lymph nodes will be considered for trial participation. In Part A, the following dose levels will apply. Each participant will be in one condition. Each condition will be examined by MMUS at 7hours, 24hours, 48hours \&72hours post dose: * Condition1: Dose 1: 28 mg Fe (7 mg Fe/mL, 4 ml in total ) * Condition2: Dose 2: 56 mg Fe (3,5 mg Fe/mL, 16 mL in total) * Condition3: Dose 2: 56 mg Fe (14 mg Fe/mL, 4 mL in total) * Condition4: Dose 3: 112 mg Fe (14 mg Fe/mL, 8 mL in total) In Part B, the dose level to be applied will be decided based on the outcome of Part A.
| Arm | Type | Receives |
|---|---|---|
| Dosing of IMP followed by MMUS evaluation | Experimental | Drug: Iron oxide nanoparticles, Device: Rectal Magnetomotoric ultrasound (MMUS)In Part A, Each condition will be evaluated with MMUS after 7hours, 24hours 48hours and 72hours. The following conditions will apply: Condition 1: Dose 1: 28 mg Fe (7 mg Fe/mL) Condition 2: Dose 2: 56 mg Fe (3,5 mg Fe/mL) Condition 3: Dose 2: 56 mg Fe (14 mg Fe/mL) Condition 4: Dose 3: 112 mg Fe (14 mg Fe/mL) In Part B, the dose level to be applied as well as the timepoint from MMUS evaluation, will be decided based on the outcome of Part A. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Part A
- Willing and able to give written informed consent for participation in the trial.
- Healthy male participant, or female participant of non-childbearing potential aged 18 to 50 years, inclusive.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator. (Discussion is encouraged between the Investigator and the Sponsor Medical Representative regarding the clinical relevance of any abnormal laboratory value during the pre dose period).
Key exclusion criteria (26 listed)
- Part A
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
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 |
|---|---|---|
| Iron oxide nanoparticlesAlso: contrast agentSubmucosal injection of nanoparticles in rectum, 28 mg Fe (7 mg Fe/mL) | Drug | Dosing of IMP followed by MMUS evaluation |
| Rectal Magnetomotoric ultrasound (MMUS)MMUS examination of lymphnodes in rectum | Device | Dosing of IMP followed by MMUS evaluation |
| Iron oxide nanoparticlesAlso: Contrast agentSubmucosal injection in rectum 56 mg Fe (3,5 mg Fe/mL) | Drug | Dosing of IMP followed by MMUS evaluation |
| Iron oxide nanoparticlesAlso: contrast agentSubmucosal injection in rectum : 56 mg Fe (14 mg Fe/mL) | Drug | Dosing of IMP followed by MMUS evaluation |
| Iron oxide nanoparticlesAlso: contrast agentSubmucosal injection in rectum 112 mg Fe (14 mg Fe/mL) | Drug | Dosing of IMP followed by MMUS evaluation |
Primary outcome
Part A: Normalised average nTrace value for all lymph nodes at all timepoints
Time frame: From dosing and up to 72 hours.
Dose-response curve and Time-response curve for normalised average nTrace value. nTrace value is NanoEcho visualisation of the movement generated by the nanoparticles
Part B, Normalised average nTrace value for all lymph nodes
Time frame: From dosing to end of MMUS examination up to 72 hours
16 secondary outcomes
Part A. Size of lymph nodes with and without detectable nTrace in Healthy Volunteers
Time frame: From dosing and up to 72 hours after dosing
Part A, Frequency, seriousness, and intensity of adverse events (AEs) for the IMP and the medical device.
Time frame: From dosing until end of study Day 8 after dosing
Part A. User experience
Time frame: From dosing up to 72 hours
Part B. Number of lymph nodes detected by NanoEcho diagnostic method compared to historic MRI data per section and overall
Time frame: After the MMUS examination up to 72 hours after dosing
Part B, True positive fraction (N+) (sensitivity) and true negative fraction (N0) (specificity) of identified lymph node per section of rectum.
Time frame: At end of MMUS examination up to 72 hours after dosing
Part A. Distance from injection to lymphnodes with and without detectable nTrace
Time frame: From dosing and up to 72 hours after dosing
Part B. Size of lymph nodes with and without detectable nTrace in Rectal Cancer patients
Time frame: From dosing and up to 72 hours after dosing
Part B, Frequency, seriousness, and intensity of adverse events (AEs) for the IMP and the medical device.
Time frame: From dosing until end of study Day 8 after dosing
Part B. User experience
Time frame: From dosing up to 72 hours
Part B. Distance from injection to lymph nodes with and without detectable nTrace in Rectal Cancer Patients
Time frame: From dosing and up to 72 hours after dosing
Part B, Size of detectable metastases
Time frame: End of MMUS examination up to 72 hours after dosing
Part B, distance form tumour to detectable tumour infiltration
Time frame: End of MMUS examination up to 72 hours after dosing
Part A, Frequency and nature of device deficiencies (DDs).
Time frame: From dosing until end of last examination after 72 hours
Part A, Safety and Tolerability of NEP 1 and NanoEcho Imaging Device examination in healthy volunteers.
Time frame: From dosing until end of study Day 8 after dosing
Part B, Frequency and nature of device deficiencies (DDs).
Time frame: From dosing until end of last MMUS examination after 72 hours after dosing
Part B, Safety and Tolerability of NEP 1 and NanoEcho Imaging Device examination in Rectal Cancer Patients
Time frame: From dosing until end of study Day 8 after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlies results in a publication
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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.
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 Iron oxide nanoparticles and Rectal Magnetomotoric ultrasound (MMUS) in people with Healthy Volunteers and Rectal Cancer Patients, run by NanoEcho 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 15 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 18 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrika Axelsson UA Axelsson, PhD (+46703824432, ua@nanoecho.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Normalised average nTrace value for all lymph nodes at all timepoints (time frame: From dosing and up to 72 hours.). The study lists 2 primary outcomes in all. 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 18 Nov 2024.