[Ga-68]MTP220 PET for Biodistribution and Efficacy in Pancreatic Cancer and Head and Neck Cancers
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- Qiubai Li
- Study ID
- NCT07026981
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Cancer Pancreas
- Head and Neck Cancer
- Pancreatic Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- [Ga-68]MTP220 PET/CT Scan — DRUGParticipants will undergo PET/CT imaging after they have received an injection of the targeted PET tracer drug, \[Ga-68\]MTP220.
Study Details
The goal of this research study is to develop a diagnostic tool to help with detection and diagnosis of head and neck cancer (HNC) and pancreatic cancer (PaC). This tool is called a "targeted PET tracer", or more specifically a drug named "\[Ga-68\]MTP220". The U.S. Food and Drug Administration (FDA) has not yet approved this drug, so researchers are conducting this research study to see if \[Ga-68\]MTP220 is safe and effective at diagnosing pancreatic cancer and head and neck cancer. FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application. Participants will receive a single injection of \[Ga-68\]MTP220 followed by PET/CT imaging at three points after they received the drug. These study procedures will take about 2.5 hours. Participants will also receive a follow-up phone call the day after receiving the drug to talk about any side effects they experienced.
Key Dates
- Start date
- Sep 30, 2025
- Status verified
- Aug 2025
- Primary completion
- Jul 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: [Ga-68]MTP220 PET/CT ImagingParticipants will receive an injection of 210 MBq (3.0-6.0 mCi, range 110-220 MBq with an upper limit of 220 MBq) of \[Ga68\]MTP220 by slow IV push. This will be followed by PET/CT imaging. One diagnostic CT scan will be performed followed by a sequential whole body PET scan (including 7 to 8 fields-of-view depending on participant height) at three points after the injection of the drug. These three points will be 20, 60 and 100 minutes after the injection. Imaging will be performed for about 1 minute per bed position. The total duration of PET data acquisition is about 20-30 minutes.
Primary Outcome Measure
Biodistribution of [Ga-68]MTP220 in patients with pancreatic cancer and head and neck cancers, as measured by standardized uptake value (SUV) mean and maximum [ Time Frame: Time it takes to do imaging study procedures, about 2.5 hours ]
Central Contacts
- Lauren Hahn216-844-9312
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | Lauren Hahn |
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