Clinical trial · Interventional
[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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pancreas | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [Ga-68]MTP220 PET/CT Scan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [Ga-68]MTP220 PET/CT Imaging
- description
- 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.
- interventionNames
- Drug: [Ga-68]MTP220 PET/CT Scan
Primary outcomes (2)
- 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
- timeFrame
- Time it takes to do imaging study procedures, about 2.5 hours
- measure
- Radiation dosimetry of [Ga-68]MTP220, as measured by dosimetry calculations performed using site software
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 Exclusion Criteria: * Participants who do not meet the above mentioned inclusion criteria * 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.
References
Publications (0)
Data not yet available