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

NCT07026981 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: CASE1Y25
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Pancreatic Cancer; Cancer Pancreas

Keywords

[Ga68]MTP220; Positron Emission Tomography Computed Tomography; PET CT Scan

Outcome Measures

Primary Outcomes (2)

• 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 it takes to do imaging study procedures, about 2.5 hours

• Radiation dosimetry of [Ga-68]MTP220, as measured by dosimetry calculations performed using site software

  Time it takes to do imaging study procedures, about 2.5 hours

Secondary Outcomes (8)

• Safety of [Ga-68]MTP220, as measured by number of participants who experience adverse events (AEs)

  Participants will be asked to report AEs via telephone follow-up no more than 1 day after they undergo study imaging

• Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood pressure

  Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes

• Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in heart rate

  Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes

• Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in respiratory rate

  Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes

• Safety of [Ga-68]MTP220, as measured by number of participants who experience a significant change in blood oxygen saturation

  Baseline (10 minutes before dose) and at the following points after they received the dose: 10, 50, 90, 140 minutes

Study Arms (1)

[Ga-68]MTP220 PET/CT Imaging

EXPERIMENTAL

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.

Drug: [Ga-68]MTP220 PET/CT Scan

Interventions

[Ga-68]MTP220 PET/CT Scan DRUG

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

[Ga-68]MTP220 PET/CT Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qiubai Li: lead

Study Sites (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Qiubai Li, MD

  Case Comprehensive Cancer Center, University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Hahn

CONTACT

216-844-9312; Lauren.Hahn@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)