TheranosticTrials.org

Clinical Trial · NCT02683824

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

Overview

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.

Sponsor

Stanford University

Phase

Early Phase 1

Contacts

Andrei Iagaru (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02683824

Drug / Compound

FP-R01-MG-F2

Isotope(s):
Target(s):
  • αvβ6
Ligand Class: Small Proteins and Antibody Fragments
Linker: fluoropropionate

Eligibility

Inclusion

  • 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
  • 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.
  • Healthy volunteers:
  • 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:

Exclusion

  • History of renal insufficiency (only for MRI contrast administration)
  • Participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements
  • Participant is not able to comply with the study procedures
  • Patients who are not likely to comply with the protocol requirements.Pancreatic cancer subjects:
  • Pregnant or breast feeding women.
  • Healthy volunteers:
  • Metallic implants (contraindicated for MRI)
  • Participant is pregnant or breast-feeding