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

Status: complete

This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 positron emission tomography (PET)/computed tomography (CT) or PET magnetic resonance imaging (MRI) in measuring response in patients with pancreatic cancer and healthy volunteers. Integrins, such as integrin alpha-v-beta [18F]-R01-MG-F2, are a family of membrane receptors that are overexpressed and attaches to various proteins which sense and respond to contact events that occur at the cell surface and may improve early detection of pancreatic cancer and improve patient selection for anti-integrin alpha-v-beta 6 therapy.

Inclusion Criteria

HEALTHY VOLUNTEER INCLUSION CRITERIA:
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
PANCREATIC CANCER PATIENT INCLUSION CRITERIA:
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 VOLUNTEER EXCLUSION CRITERIA:
Pregnant or nursing
PANCREATIC CANCER PATIENT EXCLUSION CRITERIA:
Participant is pregnant or breast-feeding
Patients is not able to  comply with the study procedures
Patients 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)

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 or PET/MRI scanning in patients with pancreatic cancer.

OUTLINE:

Patients receive fluorine F-18 FP-R01-MG-F2 intravenously (IV) and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.

After completion of study, patients are followed up at 12 months.

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

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Trial Objectives and Outline

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