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

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.

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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio