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.
For HNC, the overall 5-year survival rate of HNSCCs remains ∼40-50%. PaCa is the 3rd leading cause of cancer mortality in the US with its incidence expected to double by 2030. The poor survival of HNC and PaCa patients is partly due to the delayed diagnosis. Thus, early detection and diagnosis is pivotal to improve the survival. Currently, there is still an unmet clinical need for novel diagnostic technologies for early accurate detection and diagnosis of HNC and PaCa. In this exploratory first in human phase 0 trial, researchers are testing the use of a \[Ga-68\]MTP220 as a targeted PET tracer to explore the biodistribution, dosimetry, efficacy and safety in pancreatic and head and neck cancer patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Participants will undergo PET/CT imaging after they have received an injection of the targeted PET tracer drug, \[Ga-68\]MTP220.
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
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 frame: 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 frame: Time it takes to do imaging study procedures, about 2.5 hours
Safety of [Ga-68]MTP220, as measured by number of participants who experience adverse events (AEs)
Time frame: 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
Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test
Time frame: 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
Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test
Time frame: 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
Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test
Time frame: 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
Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test
Time frame: 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 electrocardiogram (ECG)
Changes in ECG will be summarized using descriptive statistics
Time frame: Baseline (10 minutes before dose) and at the following points after the start of they received the dose: 10 and 140 minutes
Efficacy of [Ga-68]MTP220 PET/CT imaging in detecting PaCa or HNC, as measured by comparison of tumor vs normal tissue uptake of [Ga-68]MTP220, compared to conventional imaging (when available)
Uptake of \[Ga-68\]MTP-220 will be assessed by comparing lesion uptake to background activity
Time frame: Time it takes to do imaging study procedures, about 2.5 hours
Potential of [Ga-68]MTP220 PET/CT for assessing tumor response to immunotherapy in PaCa and HNC, as measured by radiotracer uptake in tumors as compared to background activity, compared to conventional imaging (when available)
A tumor uptake that is low or approaching background levels-reflected by a low SUVmax is suggestive of a favorable treatment response. In contrast, persistently high uptake may indicate disease progression
Time frame: Time it takes to do imaging study procedures, about 2.5 hours
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