Head and Neck Squamous Cell CarcinomaPhase 1NCT06540443
Pilot Study of MPB-2043 Enhanced MRI for Nodal Staging in Head and Neck Squamous Cell Carcinomas
A Phase 1 study testing MPB-2043 of 0.5 mg/kg, MPB-2043 of 1.0 mg/kg and MPB-2043 of 2.0 mg/kg in people with Head and Neck Squamous Cell Carcinoma and Lymph Node Metastasis, run by MegaPro Biomedical Co. Ltd. at 1 site in Taiwan.
Trial summary
This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Lymph Node Metastasis
- What is being tested?
- MPB-2043 of 0.5 mg/kg, MPB-2043 of 1.0 mg/kg and MPB-2043 of 2.0 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Dec 2024to Sep 2026
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 20 years and above
- Subjects with histologically proven head and neck squamous cell carcinomas or with suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2) without previous treatment by surgery
- Based on the site's clinical practice, subjects require lymphadenectomy treatment within 8 weeks.
- Subjects must be nonlactating.
- Subjects must be able to understand and be willing to sign a written informed consent document.
- Subjects must be able to comply with the study protocol.
Who cannot join
- Subjects with contraindications to MRI
- Subjects with a serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e., Gd-based, SPIO particles, and iodinated contrast agents).
- Subjects obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment.
- Subjects who participated in another imaging-related clinical trial 30 days prior to the study enrollment.
- Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.
- Subjects with kidney disease or impairment.
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- Subjects with liver or spleen disease or impairment based on other clinical imaging, such as CT or gadolinium contrast MRI, and clinical laboratory results.
- Subjects with active hepatitis B or hepatitis C infection.
- Subjects with bone marrow disorders or a history of a bone marrow transplant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Pei-Jen Lou, MD., PhD, +886-2-2312-3456, pjlou@ntu.edu.tw
About this study
Official title: A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas
This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. The study compares four doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) and assesses the optimal timing for post-dose imaging using T1/T2/T2*-weighted sequences to improve the accuracy of nodal staging.
Read the detailed description
The accurate detection of metastatic lymph nodes in subjects with head and neck squamous cell carcinomas is essential for appropriate staging and treatment planning. Traditional imaging techniques often struggle with detecting small nodal metastases due to limitations in resolution and contrast. Superparamagnetic iron oxide (SPIO) particles, such as MPB-2043, have shown promise as MRI contrast agents, particularly in the detection of metastatic lesions in the liver. This study extends the application of SPIO-enhanced MRI to the detection of metastatic cervical lymph nodes.
In this study, T1/T2/T2*-weighted MRI sequences will be used to assess signal intensity (SI) changes in lymph nodes after the administration of MPB-2043. The susceptibility effects of the iron oxide core cause tissue signal loss, which is more pronounced in normal lymph nodes taken up by the reticuloendothelial system, allowing for differentiation from malignant lymph nodes. The study will evaluate the safety and effectiveness of four different doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) in enhancing the visualization of cervical lymph nodes and will determine the most appropriate timing for post-dose imaging.
The primary objectives include determining the dose that provides optimal contrast enhancement without compromising safety and identifying the time points post-injection that offer the best differentiation between malignant and non-malignant lymph nodes. The results of this pilot feasibility study will inform the development of more extensive clinical trials aimed at improving the diagnostic accuracy of MRI in patients with head and neck squamous cell carcinomas.
- Being tested
- MPB-2043 of 0.5 mg/kg, MPB-2043 of 1.0 mg/kg, MPB-2043 of 2.0 mg/kg, MPB-2043 of 3.0 mg/kg
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPB-2043 of 0.5 mg/kgDrug
Also called MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
MPB-2043 of 1.0 mg/kgDrug
Also called MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
MPB-2043 of 2.0 mg/kgDrug
Also called MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
MPB-2043 of 3.0 mg/kgDrug
Also called MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Dose cohort 1 | Experimental | pre- and post-enhanced MRI Receives: Drug: MPB-2043 of 0.5 mg/kg |
| Dose cohort 2 | Experimental | pre- and post-enhanced MRI Receives: Drug: MPB-2043 of 1.0 mg/kg |
| Dose cohort 3 | Experimental | pre- and post-enhanced MRI Receives: Drug: MPB-2043 of 2.0 mg/kg |
| Dose cohort 4 | Experimental | pre- and post-enhanced MRI Receives: Drug: MPB-2043 of 3.0 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of MPB-2043 Enhanced MRI in Detecting Lymph Node Metastasis
- Sensitivity is the proportion of true positive lymph nodes (those confirmed as metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change of 20% on T2*-weighted sequences post-injection is considered indicative of metastasis.
- Specificity is the proportion of true negative lymph nodes (those confirmed as non-metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change ≥ 50% on T2*-weighted sequences post-injection is considered indicative of non-metastasis.
Measured: Measured at pre-injection (Baseline) and 24 hours post-injection.
Secondary outcomes (5)
Changes in Signal Intensity of Lymph Nodes in Head and Neck MRI
This outcome measure will assess and compare the changes in signal intensity (SI) in MRI images of lymph nodes in the head and neck region taken before and after the administration of MPB-2043.
The SI changes will be evaluated across T1, T2, and T2*-weighted sequences.
Measured: From baseline to 10 minutes post-injection, and 24 hours post-injection.
Number and Size of Lymph Nodes Detected in Head and Neck
This outcome measure will record and evaluate the number and size of lymph nodes detected in the head and neck region/level via MRI post-administration of MPB-2043. The effectiveness of MPB-2043 in enhancing lymph node visibility and characterization will be determined by comparing these parameters before and after administration.
Measured: Measured at pre-injection (Baseline) and 24 hours post-injection.
Determination of Optimal MPB-2043 Dosage for Lymph Node Imaging in Head and Neck MRI
This outcome measure will determine the most suitable dosage of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, 3 mg/kg) for optimal MRI contrast enhancement of lymph nodes in the head and neck region. The assessment will be based on post-dose MRI results, specifically evaluating signal intensity changes at 24 hours post-administration.
Measured: Measured at pre-injection (Baseline) and 24 hours post-injection.
Safety Variables of Adverse Events
- The incidence of all adverse events
- Treatment-emergent adverse events (AEs)
- Serious AEs
- Any AEs leading to withdrawal of study treatment
- Any AEs leading to study discontinuation
- Any AEs leading to death
The data will be categorized and reported based on severity (mild, moderate, severe) and relatedness to the study drug, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From baseline to Day 28 post-MPB-2043 administration.
Safety Variables of Clinical Laboratory Tests
Clinical laboratory and vital sign data will be assessed for safety.
This outcome measure evaluates the incidence of abnormal findings in clinical laboratory tests following the administration of MPB-2043. The tests include hematology (e.g., complete blood count), biochemistry (e.g., liver and kidney function tests), coagulation profiles (e.g., PT, INR, aPTT), and urinalysis. Results will be categorized as 'Normal,' 'Abnormal, Not Clinically Significant (NCS),' or 'Abnormal, Clinically Significant (CS).'
Measured: From baseline to Day 28 post-MPB-2043 administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start19 Dec 2024
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MegaPro Biomedical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Pei-Jen Lou, MD., PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540443
- Sponsor's protocol ID
- IOP-CT-006
- Status last verified
- May 2025
- First submitted
- 10 Jul 2024
- Last updated
- 8 May 2025
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of MPB-2043 Enhanced Magnetic Resonance Imaging (MRI) for Nodal Staging in Subjects With Head and Neck Squamous Cell Carcinomas
- ClinicalTrials.gov ID
- NCT06540443
- Acronym / sponsor ID
- IOP-CT-006
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- MegaPro Biomedical Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 Aug 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.
This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. The study compares four doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) and assesses the optimal timing for post-dose imaging using T1/T2/T2*-weighted sequences to improve the accuracy of nodal staging.
Detailed description
The accurate detection of metastatic lymph nodes in subjects with head and neck squamous cell carcinomas is essential for appropriate staging and treatment planning. Traditional imaging techniques often struggle with detecting small nodal metastases due to limitations in resolution and contrast. Superparamagnetic iron oxide (SPIO) particles, such as MPB-2043, have shown promise as MRI contrast agents, particularly in the detection of metastatic lesions in the liver. This study extends the application of SPIO-enhanced MRI to the detection of metastatic cervical lymph nodes.
In this study, T1/T2/T2*-weighted MRI sequences will be used to assess signal intensity (SI) changes in lymph nodes after the administration of MPB-2043. The susceptibility effects of the iron oxide core cause tissue signal loss, which is more pronounced in normal lymph nodes taken up by the reticuloendothelial system, allowing for differentiation from malignant lymph nodes. The study will evaluate the safety and effectiveness of four different doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) in enhancing the visualization of cervical lymph nodes and will determine the most appropriate timing for post-dose imaging.
The primary objectives include determining the dose that provides optimal contrast enhancement without compromising safety and identifying the time points post-injection that offer the best differentiation between malignant and non-malignant lymph nodes. The results of this pilot feasibility study will inform the development of more extensive clinical trials aimed at improving the diagnostic accuracy of MRI in patients with head and neck squamous cell carcinomas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose cohort 1 | Experimental | Drug: MPB-2043 of 0.5 mg/kgpre- and post-enhanced MRI |
| Dose cohort 2 | Experimental | Drug: MPB-2043 of 1.0 mg/kgpre- and post-enhanced MRI |
| Dose cohort 3 | Experimental | Drug: MPB-2043 of 2.0 mg/kgpre- and post-enhanced MRI |
| Dose cohort 4 | Experimental | Drug: MPB-2043 of 3.0 mg/kgpre- and post-enhanced MRI |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged 20 years and above
- Subjects with histologically proven head and neck squamous cell carcinomas or with suspicious metastatic lymph nodes (≥ pathological T-stage 1 and 2) without previous treatment by surgery
- Based on the site's clinical practice, subjects require lymphadenectomy treatment within 8 weeks.
- Subjects must be nonlactating.
- Subjects must be able to understand and be willing to sign a written informed consent document.
Key exclusion criteria (9 listed)
- Subjects with contraindications to MRI
- Subjects with a serious allergic history or known allergy to similar ingredients of the study contrast agent (i.e., Gd-based, SPIO particles, and iodinated contrast agents).
- Subjects obtained gadolinium-enhanced MRI ≤ 7 days before the enrollment.
- Subjects who participated in another imaging-related clinical trial 30 days prior to the study enrollment.
- Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.
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 |
|---|---|---|
| MPB-2043 of 0.5 mg/kgAlso: MPB-2043 enhanced MRIParticipants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour. | Drug | Dose cohort 1 |
| MPB-2043 of 1.0 mg/kgAlso: MPB-2043 enhanced MRIParticipants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour. | Drug | Dose cohort 2 |
| MPB-2043 of 2.0 mg/kgAlso: MPB-2043 enhanced MRIParticipants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour. | Drug | Dose cohort 3 |
| MPB-2043 of 3.0 mg/kgAlso: MPB-2043 enhanced MRIParticipants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour. | Drug | Dose cohort 4 |
Primary outcome
Sensitivity and Specificity of MPB-2043 Enhanced MRI in Detecting Lymph Node Metastasis
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
1. Sensitivity is the proportion of true positive lymph nodes (those confirmed as metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change of 20% on T2*-weighted sequences post-injection is considered indicative of metastasis. 2. Specificity is the proportion of true negative lymph nodes (those confirmed as non-metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change ≥ 50% on T2*-weighted sequences post-injection is considered indicative of non-metastasis.
5 secondary outcomes
Changes in Signal Intensity of Lymph Nodes in Head and Neck MRI
Time frame: From baseline to 10 minutes post-injection, and 24 hours post-injection.
Number and Size of Lymph Nodes Detected in Head and Neck
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
Determination of Optimal MPB-2043 Dosage for Lymph Node Imaging in Head and Neck MRI
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
Safety Variables of Adverse Events
Time frame: From baseline to Day 28 post-MPB-2043 administration.
Safety Variables of Clinical Laboratory Tests
Time frame: From baseline to Day 28 post-MPB-2043 administration.
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 8 May 2025.
- 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.
Pei-Jen Lou, MD., PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MPB-2043 of 0.5 mg/kg, MPB-2043 of 1.0 mg/kg and MPB-2043 of 2.0 mg/kg in people with Head and Neck Squamous Cell Carcinoma and Lymph Node Metastasis, run by MegaPro Biomedical Co. Ltd. at 1 site in Taiwan.
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 6 inclusion and 9 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 8 May 2025. 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 Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jill Tsai, MD (+886-35910360, jilltsai@megaprobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of MPB-2043 Enhanced MRI in Detecting Lymph Node Metastasis (time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.). 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 8 May 2025.