NCT02683824

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

Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy Subject
• Pancreatic Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Computed Tomography	Undergo CT scan
OTHER	Laboratory Biomarker Analysis	Correlative studies
DIAGNOSTIC_TEST	PET/MRI scan	Undergo PET/MRI scan
DRUG	[18F]FP-R01-MG-F2	radioactive tracer

Timeline

• Start date: 2016-01-12
• Primary completion: 2021-09-27
• Completion: 2022-12-01
• First posted: 2016-02-17
• Last updated: 2023-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study