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

Trial ID or NCT#

NCT02683824

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. Healthy volunteers:
    1. 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.
  2. Pancreatic cancer subjects:
    1. 1. Participant must be 18 years or older at the time of radiotracer administration2. Provides written informed consent3. 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:
  1. Healthy volunteers:
    1. 1. Participant is less than 18 year-old2. Pregnant or breast feeding women.3. Patients who are not likely to comply with the protocol requirements.
  2. Pancreatic cancer subjects:
    1. 1. Participant is pregnant or breast-feeding2. Participant is not able to comply with the study procedures3. Participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements4. Metallic implants (contraindicated for MRI)5. History of renal insufficiency (only for MRI contrast administration)
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Investigator(s)

Andrei Iagaru
Andrei Iagaru
Radiologist
Professor of Radiology (Nuclear Medicine)
Walter Park
Walter Park
Gastroenterologist, Pancreas specialist, Gastrointestinal specialist, Pancreatologist
Associate Professor of Medicine (Gastroenterology and Hepatology)
Sanjiv Sam Gambhir, MD, PhD

Contact us to find out if this trial is right for you.

Contact

Mahima Goel
650-723-0371

View on ClinicalTrials.gov