NCT07026981

[Ga-68]MTP220 PET for Biodistribution and Efficacy in Pancreatic Cancer and Head and Neck Cancers

Exploratory, Prospective, Single-Arm, Open-labeled Study of [Ga68]MTP220 PET for First-in-Human Biodistribution and Efficacy in Patients With Pancreatic Cancer and Head and Neck Cancers

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Qiubai Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

For HNC, the overall 5-year survival rate of HNSCCs remains ∼40-50%. PaCa is the 3rd leading cause of cancer mortality in the US with its incidence expected to double by 2030. The poor survival of HNC and PaCa patients is partly due to the delayed diagnosis. Thus, early detection and diagnosis is pivotal to improve the survival. Currently, there is still an unmet clinical need for novel diagnostic technologies for early accurate detection and diagnosis of HNC and PaCa. In this exploratory first in human phase 0 trial, researchers are testing the use of a \[Ga-68\]MTP220 as a targeted PET tracer to explore the biodistribution, dosimetry, efficacy and safety in pancreatic and head and neck cancer patients.

Conditions

• Head and Neck Cancer
• Pancreatic Cancer
• Cancer Pancreas

Interventions

Type	Name	Description
DRUG	[Ga-68]MTP220 PET/CT Scan	Participants will undergo PET/CT imaging after they have received an injection of the targeted PET tracer drug, \[Ga-68\]MTP220.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2025-06-18
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study