NCT01741597

Dynamic Contrast Enhanced MRI in Patients With Advanced Breast or Pancreatic Cancer With Metastases to the Liver or Lung

A First Time in Human Phase I Imaging Study of iRGD in Patients With Advanced Breast and Pancreas Cancer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in patients with advanced breast or pancreatic cancer with metastases to the liver or lung. Diagnostic procedures, such as DCE-MRI, may help measure a patient's response to treatment

Detailed description

PRIMARY OBJECTIVES: I. To explore the ability of iRGD (tumor-homing peptide iRGD) to elicit changes in metastatic breast cancer vascular permeability as measured by dynamic contrast enhanced (DCE) MRI. II. To evaluate the pharmacokinetics of iRGD. III. To explore the safety of iRGD. SECONDARY OBJECTIVES: I. To explore changes in water diffusion status in tumors due to iRGD as measured by diffusion-weighted (DWI) MRI. II. To explore the ability of iRGD to elicit changes in primary pancreatic cancer vascular permeability as measured by dynamic contrast enhanced (DCE) MRI. III. To explore changes in water diffusion status in primary pancreatic cancer due to iRGD as measured by DWI-MRI. OUTLINE: Patients undergo DCE-MRI on day 1 and undergo tumor-homing peptide iRGD DCE-MRI on day 2. After completion of study treatment, patients are followed up for 15 days.

Conditions

• Acinar Cell Adenocarcinoma of the Pancreas
• Duct Cell Adenocarcinoma of the Pancreas
• Liver Metastases
• Lung Metastases
• Recurrent Breast Cancer
• Recurrent Pancreatic Cancer
• Stage IV Breast Cancer
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Undergo DCE-MRI
OTHER	pharmacological study	Correlative studies
BIOLOGICAL	tumor-homing peptide iRGD	Undergo tumor-homing peptide iRGD DCE-MRI

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-07-01
• First posted: 2012-12-05
• Last updated: 2014-05-30

Locations

1 site across 1 country: United States