Clinical trialPhase 1Withdrawn
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
- Outcome
- Stopped earlyPI chose to close the study (Other)
- Phase
- Phase 1
- Status
- Withdrawn
- Study type
- Interventional
- Start
- July 2014
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- Change in volume transfer coefficient (Ktrans) during DCE-MRI with tumor-homing peptide iRGD compared to a baseline DCE-MRI without tumor-homing peptide iRGD
- Sponsor
- Other
- Results posted
- No
- Last update
- 30 May 2014
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.