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

Primary Purpose

Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
copper Cu 64-DOTA-trastuzumab
positron emission tomography
laboratory biomarker analysis
Computed Tomography
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenocarcinoma of the Gastroesophageal Junction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)

Arm Description

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

Outcomes

Primary Outcome Measures

Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
The reading of the 64CuDOTA-trastuzumab-PET imaging of the study subjects were performed by two radiologists, one who read the first scan and the second nuclear radiologist read the remaining seven scans. To eliminate potential bias, the second nuclear radiologist was blinded to the HER2 status of the tumors as well as the location of the tumor until radiolabeled uptake was measured. XD (version 3.6; Miranda Medical) was used for image analysis.Tumor visualized as "hot" relative to adjacent tissue reported per radiologist as negative, positive, equivocal or unknown.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2013
Last Updated
May 9, 2023
Sponsor
City of Hope Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01939275
Brief Title
64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer
Official Title
64Cu-DOTA-trastuzumab Positron Emission Tomography in Patients With Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2014 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
Arm Type
Experimental
Arm Description
Patients receive copper Cu 64-DOTA-trastuzumab IV on day 1 and then undergo PET/CT scan on days 2 or 3.
Intervention Type
Radiation
Intervention Name(s)
copper Cu 64-DOTA-trastuzumab
Other Intervention Name(s)
64Cu-DOTA-trastuzumab
Intervention Description
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
Intervention Type
Device
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
Primary Outcome Measure Information:
Title
Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
Description
The reading of the 64CuDOTA-trastuzumab-PET imaging of the study subjects were performed by two radiologists, one who read the first scan and the second nuclear radiologist read the remaining seven scans. To eliminate potential bias, the second nuclear radiologist was blinded to the HER2 status of the tumors as well as the location of the tumor until radiolabeled uptake was measured. XD (version 3.6; Miranda Medical) was used for image analysis.Tumor visualized as "hot" relative to adjacent tissue reported per radiologist as negative, positive, equivocal or unknown.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanghee Woo, MD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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

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