NCT07026981Not yet recruitingEarly phase 1
[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
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- Sept 2025
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Qiubai Li
- Diseases
- Head and neck cancer, Pancreatic cancer
- NCT number
- NCT07026981
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 12
- From Sept 2025 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
Lab values
- 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)
Age
- Participants \< 18 years old
Other
- Participants who do not meet the above mentioned inclusion criteria
- Participants who refuse to give or are unable to sign the informed consent
- Participants unable to withstand or undergo PET/CT
- Pregnant or breast feeding women.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.