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

Early Phase 1

Completed

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

Brief Summary: 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: 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.

Recruitment & Eligibility

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:

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)

Arm && Interventions

Group	Intervention	Description
pancreatic cancer patients	Computed Tomography	Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
pancreatic cancer patients	Laboratory Biomarker Analysis	Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
pancreatic cancer patients	PET/MRI scan	Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
pancreatic cancer patients	[18F]FP-R01-MG-F2	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	Computed Tomography	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	Laboratory Biomarker Analysis	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	PET/MRI scan	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	[18F]FP-R01-MG-F2	Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.

Primary Outcome Measures

Name	Time	Method
Dosimetry of [18F]FP-R01-MG-F2 (rem/mCi)	Up to 3 hours after tracer injection	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.
Biodistribution of [18F]FP-R01-MG-F2 (%ID/g)	Up to 3 hours after tracer injection	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.
Biodistribution of [18F]FP-R01-MG-F2 (SUV)	Up to 3 hours after tracer injection	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.
Dosimetry of [18F]FP-R01-MG-F2 (mSv/MBq)	Up to 3 hours after tracer injection	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Stanford University, School of Medicine
🇺🇸
Palo Alto, California, United States