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

Stanford University

Status and phase: Completed; Early Phase 1

Conditions: Healthy Subject; Pancreatic Carcinoma

Treatments: Diagnostic Test: PET/MRI scan; Other: Laboratory Biomarker Analysis; Diagnostic Test: Computed Tomography; Drug: [18F]FP-R01-MG-F2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02683824

P30CA124435 (U.S. NIH Grant/Contract)

NCI-2015-01887 (Registry Identifier)

PANC0020 (Other Identifier)

4593 (Other Identifier)

IRB-34376

Details and patient eligibility

About

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.

Full description

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 scanning in patients with pancreatic cancer.

OUTLINE:

Patients receive [18F]FP-R01-MG-F2 intravenously (IV) and undergo PET/CT or PET/MR scan immediately after and at 60 and 120 minutes. Patients will be followed up at 24-48 hours.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 2 patient groups

pancreatic cancer patients

Experimental group

Description:

Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.

Treatment:

Drug: [18F]FP-R01-MG-F2

Other: Laboratory Biomarker Analysis

Diagnostic Test: Computed Tomography

Diagnostic Test: PET/MRI scan

healthy patients

Experimental group

Description:

Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.

Treatment:

Drug: [18F]FP-R01-MG-F2

Other: Laboratory Biomarker Analysis

Diagnostic Test: Computed Tomography

Diagnostic Test: PET/MRI scan