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Integrin Alpha-v-Beta and [18F]-R01-MG-F2 PET/CT in Measuring Response in Patients With Pancreatic Cancer and Healthy Volunteers
Not Recruiting
Trial ID: NCT02683824
Purpose
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.
Official Title
Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study
Stanford Investigator(s)
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Walter Park
Associate Professor of Medicine (Gastroenterology and Hepatology)
Eligibility
Inclusion Criteria:
Healthy volunteers:
1. Must be 18 years of age or older.
2. 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.
3. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
4. 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:
1. Participant must be 18 years or older at the time of radiotracer administration
2. Provides written informed consent
3. 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:
1. Participant is less than 18 year-old
2. Pregnant or breast feeding women.
3. Patients who are not likely to comply with the protocol requirements.
Pancreatic cancer subjects:
1. Participant is pregnant or breast-feeding
2. Participant is not able to comply with the study procedures
3. Participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements
4. Metallic implants (contraindicated for MRI)
5. History of renal insufficiency (only for MRI contrast administration)
Intervention(s):
drug: [18F]FP-R01-MG-F2
other: Laboratory Biomarker Analysis
diagnostic_test: Computed Tomography
diagnostic_test: PET/MRI scan
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mahima Goel
650-723-0371