Integrin Alpha-v-Beta and [18F]-R01-MG-F2 PET/CT in Measuring Response in Patients With Pancreatic Cancer and Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study

Conditions
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Healthy Subject, Pancreatic Carcinoma

Intervention / Treatment
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* Diagnostic Test: Computed Tomography
* Other: Laboratory Biomarker Analysis
* Diagnostic Test: PET/MRI scan
* Drug: [18F]FP-R01-MG-F2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers: Must be 18 years of age or older. Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained. Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose. Pancreatic cancer subjects: Participant must be 18 years or older at the time of radiotracer administration Provides written informed consent Suspected or established diagnosis of pancreatic cancer based on any radiographic scan or pathology and who is scheduled for surgery OR Biopsy proven diagnosis of pancreatic cancer who is no longer a surgical candidate Exclusion Criteria: Healthy volunteers: Participant is less than 18 year-old Pregnant or breast feeding women. Patients who are not likely to comply with the protocol requirements. Pancreatic cancer subjects: Participant is pregnant or breast-feeding Participant is not able to comply with the study procedures Participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements Metallic implants (contraindicated for MRI) History of renal insufficiency (only for MRI contrast administration)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pancreatic cancer patients<br>Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes. | Diagnostic Test: Computed Tomography<br>* Undergo CT scan<br>* Other names: tomography;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Diagnostic Test: PET/MRI scan<br>* Undergo PET/MRI scan<br>* Other names: magnetic resonance imaging;Drug: [18F]FP-R01-MG-F2<br>* radioactive tracer<br>|
| Experimental: healthy patients<br>Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes. | Diagnostic Test: Computed Tomography<br>* Undergo CT scan<br>* Other names: tomography;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Diagnostic Test: PET/MRI scan<br>* Undergo PET/MRI scan<br>* Other names: magnetic resonance imaging;Drug: [18F]FP-R01-MG-F2<br>* radioactive tracer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |