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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01887 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 4593 | |||
| PANC0020 | Other Identifier | OnCore | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 Positron Emission Tomography/Computed Tomography (PET/CT) and Positron Emission Tomography-Magnetic Resonance Imaging in (PET/MRI) in measuring response in patients with pancreatic cancer and healthy volunteers. Integrins, such as integrin alpha-v-beta-6 (avb6), are a family of membrane receptors that are overexpressed on the cell surface of pancreatic cancers. [18F]-R01-MG-F2 targets avb6, which may improve early detection of and better stratify treatment options for patients with pancreatic cancer.
PRIMARY OBJECTIVES:
I. Evaluate the biodistribution and safety of [18F]FP-R01-MG-F2 in healthy volunteers.
II. Evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in patients with pancreatic cancer.
OUTLINE:
Patients receive [18F]FP-R01-MG-F2 intravenously (IV) and undergo PET/CT or PET/MR scan immediately after and at 60 and 120 minutes. Patients will be followed up at 24-48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pancreatic cancer patients | Experimental | Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes. |
|
| healthy patients | Experimental | Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Diagnostic Test | Undergo CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of [18F]FP-R01-MG-F2 (%ID/g) | From the Region-of-Interest (ROI) image analysis, the biodistribution data will be reported in percent injected dose per gram of tissue (%ID/g). ROI analysis will be performed on normal brain, thyroid, lungs, mediastinum, liver, spleen, intestines, kidneys, urinary bladder and gluteal muscle. | Up to 3 hours after tracer injection |
| Biodistribution of [18F]FP-R01-MG-F2 (SUV) | From the Region-of-Interest (ROI) image analysis, the biodistribution data will be reported in Standardized Uptake Values (SUV). ROI analysis will be performed on normal brain, thyroid, lungs, mediastinum, liver, spleen, intestines, kidneys, urinary bladder and gluteal muscle. | Up to 3 hours after tracer injection |
| Dosimetry of [18F]FP-R01-MG-F2 (rem/mCi) | Using the biodistribution data (uptake in %ID/g or SUV), the tracer's complete dosimetry across all organs, tissues or cells will be determined using the OLINDA software. These data will be reported in rem/mCi. | Up to 3 hours after tracer injection |
| Dosimetry of [18F]FP-R01-MG-F2 (mSv/MBq) | Using the biodistribution data (uptake in %ID/g or SUV), the tracer's complete dosimetry across all organs, tissues or cells will be determined using the OLINDA software. These data will be reported in mSv/MBq. | Up to 3 hours after tracer injection |
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Inclusion Criteria:
Healthy volunteers:
Pancreatic cancer subjects:
Exclusion Criteria:
Healthy volunteers:
Pancreatic cancer subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Iagaru | Stanford Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34729628 | Derived | Nakamoto R, Ferri V, Duan H, Hatami N, Goel M, Rosenberg J, Kimura R, Wardak M, Haywood T, Kellow R, Shen B, Park W, Iagaru A, Gambhir SS. Pilot-phase PET/CT study targeting integrin alphavbeta6 in pancreatic cancer patients using the cystine-knot peptide-based 18F-FP-R01-MG-F2. Eur J Nucl Med Mol Imaging. 2022 Dec;50(1):184-193. doi: 10.1007/s00259-021-05595-7. Epub 2021 Nov 3. |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| PET/MRI scan | Diagnostic Test | Undergo PET/MRI scan |
|
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| [18F]FP-R01-MG-F2 | Drug | radioactive tracer |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D014054 | Tomography |
| D049268 | Positron-Emission Tomography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014055 | Tomography, Emission-Computed |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |
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