MRI ScanPhase 1/2NCT06262139
Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients
A Phase 1/2 study testing MT218 injection in people with MRI Scan, run by Songqi Gao at 1 site in United States.
Trial summary
This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- MRI Scan
- What is being tested?
- MT218 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to Dec 2026
- Phase
- Phase 1/2
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects aged >18 years.
- Patients with confirmed Gleason score of 8 - 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy.
- Ability to lie still for MRI scanning.
- Patients must be able to provide written informed consent.
- Glomerular filtration rate (GFR) > 60 mL/min within a 30 days of the research MRI.
Who cannot join
- Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease.
- Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections.
- Patients with uncontrolled diabetes or hypertension.
- Patients with active non-prostate malignancy.
- Patients with contraindications for MRI including implantable pace makers, cochlear implants.
- Patients with uni- or bilateral hip prosthesis.
Show all 13Show fewer
- Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments.
- Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy.
- Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result.
- Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection.
- Is determined by the investigator that the patient is clinically unsuitable for the study.
- Is incapable of understanding the language in which the information for the patient is given.
- Participation in a concurrent clinical trial or in another trial within the past 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
About this study
Official title: An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients
This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy.
Read the detailed description
Phase 1b open label, single-arm, dose-escalating investigation of safety and efficacy of a gadolinium (Gd) and peptide based MRI contrast agent (MT218) as an extradomain-B fibronectin (EDB-FN) targeted molecular MR contrast agent to detect aggressive prostate cancer with comparison of its results with the standard-of-care mutliparametic MRI (mpMRI) and PSMA PET/CT and histopathology validation in preprostatectomy patients diagnosed with prostate cancer in their clinical care.
- Conditions
- MRI Scan
- Being tested
- MT218 injection
- Keywords
- MT218, target GBCA, peptide, MRI contrast agent, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT218 injectionDrug
a targeted magnetic resonance imaging contrast agent
| Study group | Role | What they receive |
|---|---|---|
| MT218 | Experimental | Each patient will receive a single intravenous injection of MT218 while being scanned with standard MR imaging sequences/protocol. The first cohort of four subjects will receive 0.02 mmol/kg, second cohort of four subjects will receive 0.04 mmol/kg, and third cohort of four subjects will receive 0.06 mmol/kg of MT218. Receives: Drug: MT218 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with comparing the previous clinical mpMRI using the clinical standard MRI contrast agent and PSMA-PET/CT
Gleason scoring is the most common prostate cancer grading system. A Gleason score of 6 is a low-grade cancer. A Gleason score of 7 is a medium-grade cancer, and a score of 8, 9 or 10 is a high-grade cancer.
mpMRI: multi-parametric MRI; PSMA-PET/CT: prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) and Computed Tomography (CT) scan
Measured: up to 3 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start25 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRI ScanStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- prostate cancer patients
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Songqi Gao
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University
- Responsible party
- Sponsor-investigator, Songqi Gao, Molecular Theranostics LLC
- Investigators
- David Schuster, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262139
- Sponsor's protocol ID
- MT218-002
- Status last verified
- Dec 2025
- First submitted
- 23 Jan 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent (MT218) in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06262139
- Acronym / sponsor ID
- MT218-002
- Conditions
- MRI Scan
- Keywords
- MT218, target GBCA, peptide, MRI contrast agent, prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Songqi GaoIndustry (pharma, biotech, devices)
- Collaborators
- Emory University
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Feb 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 phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy.
Detailed description
Phase 1b open label, single-arm, dose-escalating investigation of safety and efficacy of a gadolinium (Gd) and peptide based MRI contrast agent (MT218) as an extradomain-B fibronectin (EDB-FN) targeted molecular MR contrast agent to detect aggressive prostate cancer with comparison of its results with the standard-of-care mutliparametic MRI (mpMRI) and PSMA PET/CT and histopathology validation in preprostatectomy patients diagnosed with prostate cancer in their clinical care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prostate cancer patients
| Arm | Type | Receives |
|---|---|---|
| MT218 | Experimental | Drug: MT218 injectionEach patient will receive a single intravenous injection of MT218 while being scanned with standard MR imaging sequences/protocol. The first cohort of four subjects will receive 0.02 mmol/kg, second cohort of four subjects will receive 0.04 mmol/kg, and third cohort of four subjects will receive 0.06 mmol/kg of MT218. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male subjects aged >18 years.
- Patients with confirmed Gleason score of 8 - 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy.
- Ability to lie still for MRI scanning.
- Patients must be able to provide written informed consent.
- Glomerular filtration rate (GFR) > 60 mL/min within a 30 days of the research MRI.
Key exclusion criteria (13 listed)
- Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease.
- Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections.
- Patients with uncontrolled diabetes or hypertension.
- Patients with active non-prostate malignancy.
- Patients with contraindications for MRI including implantable pace makers, cochlear implants.
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 |
|---|---|---|
| MT218 injectiona targeted magnetic resonance imaging contrast agent | Drug | MT218 |
Primary outcome
Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with comparing the previous clinical mpMRI using the clinical standard MRI contrast agent and PSMA-PET/CT
Time frame: up to 3 days after injection
Gleason scoring is the most common prostate cancer grading system. A Gleason score of 6 is a low-grade cancer. A Gleason score of 7 is a medium-grade cancer, and a score of 8, 9 or 10 is a high-grade cancer. mpMRI: multi-parametric MRI; PSMA-PET/CT: prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) and Computed Tomography (CT) scan
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 19 Dec 2025.
- Evaluation of Physicochemical Properties, Pharmacokinetics, Biodistribution, Toxicity, and Contrast-Enhanced Cancer MRI of a Cancer-Targeting Contrast Agent, MT218Link provided by the sponsor.
- 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.
David Schuster, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MT218 injection in people with MRI Scan, run by Songqi Gao at 1 site in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 19 Dec 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 United States. 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 combined 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.
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 David M Schuster, MD ((404)712-4859, dschust@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with comparing the previous clinical mpMRI using the clinical standard MRI contrast agent and PSMA-PET/CT (time frame: up to 3 days after 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 19 Dec 2025.