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
Andrei Iagaru

Professor of Radiology (Nuclear Medicine)

Walter Park
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

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