Acinar Cell Adenocarcinoma of the PancreasPhase 1NCT01741597
Dynamic Contrast Enhanced MRI in Patients With Advanced Breast or Pancreatic Cancer With Metastases to the Liver or Lung
A Phase 1 study testing dynamic contrast-enhanced magnetic resonance imaging, pharmacological study and tumor-homing peptide iRGD in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by City of Hope Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Liver Metastases
- What is being tested?
- dynamic contrast-enhanced magnetic resonance imaging, pharmacological study and tumor-homing peptide iRGD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Patients with an active, bleeding diathesis or requiring therapeutic anticoagulation
- Patients receiving bevacizumab within 3 months of study entry
- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- Patients should not have any uncontrolled illness including ongoing or active infection
- Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to iRGD
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A First Time in Human Phase I Imaging Study of iRGD in Patients With Advanced Breast and Pancreas Cancer
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- dynamic contrast-enhanced magnetic resonance imaging, pharmacological study, tumor-homing peptide iRGD
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
Also called DCE-MRI
Undergo DCE-MRI
Also called pharmacological studies
Correlative studies
tumor-homing peptide iRGDBiological
Also called iRGD
Undergo tumor-homing peptide iRGD DCE-MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (DCE-MRI, tumor-homing peptide iRGD) | Experimental | Patients undergo DCE-MRI on day 1 and undergo tumor-homing peptide iRGD DCE-MRI on day 2. Receives: Procedure: dynamic contrast-enhanced magnetic resonance imaging; Other: pharmacological study; Biological: tumor-homing peptide iRGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 15 days
Secondary outcomes (1)
The potential for tumor-homing peptide iRGD to enhance uptake of key anti-cancer agents
Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJul 2014
- Primary completionJul 2016 (estimated)
Why it stopped: PI chose to close the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinar Cell Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vincent Chung, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741597
- Sponsor's protocol ID
- 12228
- Other IDs
- NCI-2012-02449, P01CA043904
- Status last verified
- May 2014
- First submitted
- 3 Dec 2012
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First Time in Human Phase I Imaging Study of iRGD in Patients With Advanced Breast and Pancreas Cancer
- ClinicalTrials.gov ID
- NCT01741597
- Acronym / sponsor ID
- 12228
- Conditions
- Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Liver Metastases, Lung Metastases, Recurrent Breast Cancer, Recurrent Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI chose to close the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (estimated)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (DCE-MRI, tumor-homing peptide iRGD) | Experimental | Procedure: dynamic contrast-enhanced magnetic resonance imaging, Other: pharmacological study, Biological: tumor-homing peptide iRGDPatients undergo DCE-MRI on day 1 and undergo tumor-homing peptide iRGD DCE-MRI on day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (22 listed)
- 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:
- Presence of atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic contrast-enhanced magnetic resonance imagingAlso: DCE-MRIUndergo DCE-MRI | Procedure or surgery | Diagnostic (DCE-MRI, tumor-homing peptide iRGD) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Diagnostic (DCE-MRI, tumor-homing peptide iRGD) |
| tumor-homing peptide iRGDAlso: iRGDUndergo tumor-homing peptide iRGD DCE-MRI | Biological | Diagnostic (DCE-MRI, tumor-homing peptide iRGD) |
Primary outcome
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
Time frame: Baseline to 15 days
Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.
1 secondary outcome
The potential for tumor-homing peptide iRGD to enhance uptake of key anti-cancer agents
Time frame: Up to 15 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Chung principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dynamic contrast-enhanced magnetic resonance imaging, pharmacological study and tumor-homing peptide iRGD in people with Acinar Cell Adenocarcinoma of the Pancreas and Duct Cell Adenocarcinoma of the Pancreas, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline to 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.