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64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01939275
Recruitment Status : Active, not recruiting
First Posted : September 11, 2013
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date June 17, 2019
Study Start Date  ICMJE September 25, 2014
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
  • Tumor uptake of copper Cu 64-DOTA trastuzumab [ Time Frame: Up to 1 year ]
    Parameterized in terms of single-voxel maximum values peak standardized uptake value (SUVmax) and whole-tumor volumes of interest (SUVwhtum). Ratios of tumor to non-tumor activity concentration will be calculated. Receiver-operator curve (ROC) analysis will be performed to estimate optimal cutoff values of SUVmax, SUVwhtum, tumor:background, and tumor:organ ratios for classifying tumors as "HER2 positive" or "HER2 negative".
  • Percent of patients whose tumors image with Cu-PET/CT [ Time Frame: Up to 1 year ]
    Estimated with a 95% confidence interval (CI) half-width of 21%.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
  • Tumor uptake of copper Cu 64-DOTA trastuzumab [ Time Frame: Up to 1 year ]
    Parameterized in terms of single-voxel maximum values peak standardized uptake value (SUVmax) and whole-tumor volumes of interest (SUVwhtum). Ratios of tumor to non-tumor activity concentration will be calculated. Receiver-operator curve (ROC) analysis will be performed to estimate optimal cutoff values of SUVmax, SUVwhtum, tumor:background, and tumor:organ ratios for classifying tumors as "HER2 positive" or "HER2 negative".
  • Percent of patients whose tumors image with Cu-PET [ Time Frame: Up to 1 year ]
    Estimated with a 95% confidence interval (CI) half-width of 21%.
  • Percent of samples where the surgeon was confident they could identify areas on the tumor that corresponded to high or low areas of Cu-PET uptake [ Time Frame: Up to 1 year ]
    Estimated with a 95% CI half-width of 21%.
  • Pathologic confirmation of Cu-PET SUV variation over the tumor [ Time Frame: Up to 1 year ]
    Positive and negative areas of the tumor will be sent to pathology for confirmation. This will be exploratory.
  • Pathologic confirmation of Cu-PET SUV positive or negative cases [ Time Frame: Up to 1 year ]
    Correlative of Cu-PET SUV (measured as peak SUV) and pathology will be explored. As correlation requires a continuous measure from pathology, and some pathology will use FISH and/or IHC, this will be exploratory. Comparing Cu-PET in positive cases versus negative by pathology will depend on the percent of patients deemed positive.
Change History Complete list of historical versions of study NCT01939275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 14, 2017)
  • Percent of patients deemed negative by pathology, but appear positive by CU-PET/CT [ Time Frame: Up to 1 year ]
  • Pathologic confirmation of Cu-PET/CT SUV variation over the tumor [ Time Frame: Up to 1 year ]
    Positive and negative areas of the tumor will be sent to pathology for confirmation. This will be exploratory.
  • Pathologic confirmation of Cu-PET/CT SUV [ Time Frame: Up to 1 year ]
    Correlation of Cu-PET SUV (measured as peak SUV) and pathology will be explored. As correlation requires a continuous measure from pathology, and some pathology will use FISH and/or IHC, this will be exploratory. Comparing Cu-PET in positive cases versus negative by pathology will depend on the percent of patients deemed positive.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer
Official Title  ICMJE 64Cu-DOTA-trastuzumab Positron Emission Tomography in Patients With Gastric Cancer
Brief Summary This pilot clinical trial studies copper Cu 64 (64Cu) tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET)/computed tomography (CT) in studying patients with gastric, or stomach cancer. Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab PET/CT, may help doctors study the characteristics of tumors and choose the best treatment.
Detailed Description

PRIMARY OBJECTIVES:

I. To compare tumor uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) in gastric cancer patients with pathologic evaluation of tumor human epidermal growth factor receptor 2 (HER2)/neu expression.

II. To compare copper Cu 64-DOTA-trastuzumab-PET-CT scan with standard radiographic imaging for staging patients with gastric cancer.

OUTLINE:

Patients receive copper Cu 64-DOTA-trastuzumab intravenously (IV) on day 1 and then undergo PET/CT scan on days 2 or 3.

After completion of study, patients are followed up for 15 days and periodically for up to 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Adenocarcinoma of the Gastroesophageal Junction
  • Diffuse Adenocarcinoma of the Stomach
  • Intestinal Adenocarcinoma of the Stomach
  • Mixed Adenocarcinoma of the Stomach
  • Recurrent Gastric Cancer
  • Stage IA Gastric Cancer
  • Stage IB Gastric Cancer
  • Stage IIA Gastric Cancer
  • Stage IIB Gastric Cancer
  • Stage IIIA Gastric Cancer
  • Stage IIIB Gastric Cancer
  • Stage IIIC Gastric Cancer
  • Stage IV Gastric Cancer
Intervention  ICMJE
  • Radiation: copper Cu 64-DOTA-trastuzumab
    Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
    Other Name: 64Cu-DOTA-trastuzumab
  • Device: positron emission tomography
    Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
    Other Names:
    • FDG-PET
    • PET
    • PET scan
    • tomography, emission computed
  • Other: laboratory biomarker analysis
    Correlative studies
  • Procedure: Computed Tomography
    Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • Computerized Tomography
    • CT
    • CT Scan
    • tomography
Study Arms  ICMJE Experimental: Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
Patients receive copper Cu 64-DOTA-trastuzumab IV on day 1 and then undergo PET/CT scan on days 2 or 3.
Interventions:
  • Radiation: copper Cu 64-DOTA-trastuzumab
  • Device: positron emission tomography
  • Other: laboratory biomarker analysis
  • Procedure: Computed Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2013)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 4, 2020
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must have a histologic diagnosis of gastric or gastroesophageal junction adenocarcinoma
  • Two patients must be HER2 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) positive
  • Either the primary tumor or at least one of the metastatic lesions must be >= 2 cm
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy of >= 3 months
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days of copper Cu 64-DOTA administrations and must have agreed to use an effective contraceptive method; 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 four 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
  • CT/magnetic resonance imaging (MRI) scan must be obtained within 4 weeks prior to study entry
  • Patients must have normal cardiac ejection fraction
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • All toxicities should recover to grade 0 or 1 prior to day 1

Exclusion Criteria:

  • 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), QT interval corrected by Fridericia's formula (QTcF) > 450 msec on screening electrocardiogram (ECG), or right bundle branch block + left anterior hemiblock (bifascicular block)
  • Presence of atrial fibrillation
  • Previous history of angina pectoris or acute myocardial infarction (MI) within 6 months
  • Congestive heart failure (New York Heart Association functional classification III-IV)
  • Uncontrolled hypertension (mmHg > 160 systolic or > 90 diastolic)
  • Patients should not have active infections or concurrent neoplastic disease except for skin cancer
  • Patients may not be receiving any other investigational agents
  • At the time of enrollment, patients may not have received any biological, chemotherapy, or radiation therapy
  • Patients who may not have received trastuzumab within the prior 6 months for any other reason
  • Patients who are pregnant
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939275
Other Study ID Numbers  ICMJE 13229
NCI-2013-01721 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
13229 ( Other Identifier: City of Hope Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanghee Woo, MD City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP