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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [Ga-68]MTP220 PET/CT Imaging | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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 it takes to do imaging study procedures, about 2.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of [Ga-68]MTP220, as measured by number of participants who experience adverse events (AEs) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Hahn | Contact | 216-844-9312 | Lauren.Hahn@UHhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Qiubai Li, MD | Case Comprehensive Cancer Center, University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Changes from baseline for vital signs may be tested for differences from zero by time point using ANOVA or paired t-test |
| 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 | 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 | 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 | 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 | 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 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 it takes to do imaging study procedures, about 2.5 hours |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |