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

Study Overview
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Brief Summary
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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
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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.

Official Title
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64Cu-DOTA-trastuzumab Positron Emission Tomography in Patients With Gastric Cancer

Conditions
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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 / Treatment
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* Radiation: copper Cu 64-DOTA-trastuzumab
* Device: positron emission tomography
* Other: laboratory biomarker analysis
* Procedure: Computed Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)<br>Patients receive copper Cu 64-DOTA-trastuzumab IV on day 1 and then undergo PET/CT scan on days 2 or 3. | Radiation: copper Cu 64-DOTA-trastuzumab<br>* Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan<br>* Other names: 64Cu-DOTA-trastuzumab;Device: positron emission tomography<br>* Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan<br>* Other names: tomography, emission computed;Other: laboratory biomarker analysis<br>* Correlative studies<br>Procedure: Computed Tomography<br>* Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan<br>* Other names: tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year |