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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
3 other identifiers
interventional
N/A
1 country
1
Brief 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
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedMay 30, 2014
May 1, 2014
2 years
December 3, 2012
May 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.
Baseline to 15 days
Secondary Outcomes (1)
The potential for tumor-homing peptide iRGD to enhance uptake of key anti-cancer agents
Up to 15 days
Study Arms (1)
Diagnostic (DCE-MRI, tumor-homing peptide iRGD)
EXPERIMENTALPatients undergo DCE-MRI on day 1 and undergo tumor-homing peptide iRGD DCE-MRI on day 2.
Interventions
Undergo DCE-MRI
Correlative studies
Undergo tumor-homing peptide iRGD DCE-MRI
Eligibility Criteria
You may qualify if:
- Patient must have a histologic diagnosis of breast or pancreatic adenocarcinoma (expansion cohort) metastatic to the liver or lung
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Women of child-bearing potential must have a negative serum pregnancy test within 7 days of the first DCE-MRI and must have agreed to use an effective contraceptive method; the effects of iRGD on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Patient must have a measurable lesion at least 2 cm in size amenable to DCE-MRI study as determined by Radiology
- Computed tomography (CT)/MRI scan must be obtained within 3 weeks prior to study entry
- Absolute neutrophil count \>= 1,500/mcl
- Platelet count \>= 100,000/mcl
- Creatinine =\< 1.3 mg/dl or a measured creatinine clearance \>= 60 cc/min
- Bilirubin =\< 1.5 mg/dl
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) no greater than 2.5 times the upper limit of normal for patients with liver metastases; patients without liver metastasis should have ALT and AST no greater than 1.5 times the upper limit of normal
- Patients currently being treated for severe infections or who are recovering from major surgery or other intercurrent illnesses are ineligible until recovery is deemed complete by the investigator
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Patients with grade 2 or higher toxicity due to previous chemotherapy; all toxicities should recover to grade 0 or 1 prior to day 1
You may not qualify if:
- Patients experiencing an infusion reaction with the day 1 DCE-MRI
- Patients with any grade electrolyte abnormalities that are unable to be corrected by day 1
- Patients with a history of previous reaction to IV contrast
- Impaired cardiac function including any one of the following:
- Complete left bundle branch block or use of a permanent cardiac pacemaker
- Congenital long QT syndrome
- Presence of ventricular tachyarrhythmias
- Clinically significant resting bradycardia (\< 50 beats per minute)
- Corrected Fridericia's QT interval (QTcF) \> 450 msec on screening electrocardiogram (ECG)
- Right bundle branch block + left anterior hemiblock (bifascicular block)
- Presence of atrial fibrillation
- Previous history angina pectoris or acute myocardial infarction (MI) within 6 months
- Congestive heart failure (New York Heart Association functional classification III-IV)
- Uncontrolled hypertension (mmHg \> 140 systolic or \> 90 diastolic)
- Brain or leptomeningeal metastases
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Chung
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2012
First Posted
December 5, 2012
Study Start
July 1, 2014
Primary Completion
July 1, 2016
Last Updated
May 30, 2014
Record last verified: 2014-05