Loading clinical trials...

Dynamic Contrast Enhanced MRI in Patients With Advanced Breast or Pancreatic Cancer With Metastases to the Liver or Lung | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

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

NCT01741597•City of Hope Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+3 more criteria

Exclusion Criteria

•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)
+12 more criteria

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Key Dates

Start Date

July 1, 2014

Primary Completion Date

July 1, 2016

Last Updated

May 30, 2014

Conditions

Acinar Cell Adenocarcinoma of the PancreasDuct Cell Adenocarcinoma of the PancreasLiver MetastasesLung MetastasesRecurrent Breast CancerRecurrent Pancreatic CancerStage IV Breast CancerStage IV Pancreatic Cancer

Interventions

dynamic contrast-enhanced magnetic resonance imaging

PROCEDURE

pharmacological study

OTHER

tumor-homing peptide iRGD

BIOLOGICAL

Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction

NCT06362395

Liver Metastases

View study

RECRUITINGPHASE1/PHASE2

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

NCT07281924

Metastatic MelanomaLiver Metastases

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases

Stereotactic Magnetic Resonance Guided Radiation Therapy

Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC

Hepatic Artery Transfusion of NKG2D CAR-NK Cells Followed by Intravenous Infusion of NKG2D CAR-T Cells to Treat Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments: a Phase I Exploratory Clinical Trial