Trials / Completed
CompletedNCT01939275
64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer
64Cu-DOTA-trastuzumab Positron Emission Tomography in Patients With Gastric Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | copper Cu 64-DOTA-trastuzumab | Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan |
| DEVICE | positron emission tomography | Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan |
| OTHER | laboratory biomarker analysis | Correlative studies |
| PROCEDURE | Computed Tomography | Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan |
Timeline
- Start date
- 2014-11-19
- Primary completion
- 2019-03-30
- Completion
- 2024-08-05
- First posted
- 2013-09-11
- Last updated
- 2025-02-28
- Results posted
- 2019-10-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01939275. Inclusion in this directory is not an endorsement.