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NCT01939275Completed

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

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

Source: ClinicalTrials.gov · Last updated 28 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
8 (actual)
First submitted
6 Sept 2013
Start date
19 Nov 2014
Primary completion date
30 Mar 2019
Lead sponsor
City of Hope Medical Center
NCT number
NCT01939275

What you commit to

  • Study type: Interventional
  • Participants enrolled: 8
  • From 19 Nov 2014 to the primary completion date, 30 Mar 2019
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of angina pectoris or acute myocardial infarction (MI) within 6 months
  • 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

Other illness

  • Congestive heart failure (New York Heart Association functional classification III-IV)
  • Uncontrolled hypertension (mmHg \> 160 systolic or \> 90 diastolic)

Lab values

  • 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)

Other

  • Presence of atrial fibrillation
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.