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

NCT ID: NCT07026981

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[Ga-68]MTP220 PET/CT Imaging

Participants 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.

Group Type: EXPERIMENTAL

[Ga-68]MTP220 PET/CT Scan

Intervention Type: DRUG

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

Interventions

[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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants older than 18 years old
• Prior biopsy showing pancreatic or head and neck malignancy
• Participants have been newly diagnosed and not yet received definitive therapy (including surgery, radiation therapy, or systemic therapy).
• Able and willing to provide written informed consent before any protocol-specific procedures are undertaken
• Participants willing and able to undergo a PET/CT

• Participants with severe hepatic and renal dysfunction (Total bilirubin > 3 mg/dL, Albumin < 2.8 g/dL, INR > 2.3 (or prolonged PT), presence of ascites or hepatic encephalopathy (Grade III-IV) End-Stage Renal Disease (ESRD) or eGFR < 30 mL/min/1.73m², Serum creatinine > 4 mg/dL or rapidly rising, Need for dialysis (hemodialysis or peritoneal dialysis), uremic symptoms)
• Participants < 18 years old
• Participants who refuse to give or are unable to sign the informed consent
• Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
• Participants unable to withstand or undergo PET/CT
• Pregnant or breast feeding women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qiubai Li

OTHER

Sponsor Role: lead

Responsible Party

Qiubai Li

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qiubai Li, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center, University Hospitals

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Lauren Hahn

Role: CONTACT

Lauren.Hahn@UHhospitals.org

216-844-9312

Facility Contacts

Lauren Hahn

Role: primary

Other Identifiers

CASE1Y25

Identifier Type: -

Identifier Source: org_study_id