[Ga-68]MTP220 PET for Biodistribution and Efficacy in Pancreatic Cancer and Head and Neck Cancers
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQiubai Li
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- [Ga-68]MTP220 PET/CT Scan
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Qiubai Li
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov