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

NCT01939275 | Completed Results DMC

• 2 other identifiers: 13229NCI-2013-01721
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

EXPERIMENTAL

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; Device: positron emission tomography; Other: laboratory biomarker analysis; Procedure: Computed Tomography

Interventions

copper Cu 64-DOTA-trastuzumab RADIATION

Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan

Also known as: 64Cu-DOTA-trastuzumab

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

positron emission tomography DEVICE

Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

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

laboratory biomarker analysis OTHER

Correlative studies

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

Computed Tomography PROCEDURE

Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

64Cu-DOTA-trastuzumab; Positron-Emission Tomography; Tomography, Emission-Computed

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Limitations and Caveats

A total of 8 of the planned 22 gastric adenocarcinoma subjects met eligibility and completed the imaging with 64CuDOTA-Trastuzumab-PET/CT during the 3-year grant period.

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-812-5265

Study Officials

• Yanghee Woo, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 11, 2013
• Study Start: November 19, 2014
• Primary Completion: March 30, 2019
• Study Completion: August 5, 2024
• Last Updated: February 28, 2025
• Results First Posted: October 8, 2019

Record last verified: 2025-02

Locations

US (1)