Adenocarcinoma of the Gastroesophageal JunctionNCT01939275

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

A study testing copper Cu 64-DOTA-trastuzumab, positron emission tomography and laboratory biomarker analysis in people with Adenocarcinoma of the Gastroesophageal Junction and Diffuse Adenocarcinoma of the Stomach, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach
What is being tested?: copper Cu 64-DOTA-trastuzumab, positron emission tomography and laboratory biomarker analysis
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 19 Nov 2014to 5 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

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
Being tested: copper Cu 64-DOTA-trastuzumab, positron emission tomography, laboratory biomarker analysis, Computed Tomography
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

copper Cu 64-DOTA-trastuzumabRadiation
Also called 64Cu-DOTA-trastuzumab
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
positron emission tomographyDevice
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
laboratory biomarker analysisOther
Correlative studies
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan

Study groups in NCT01939275
Study group	Role	What they receive
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. Receives: Radiation: copper Cu 64-DOTA-trastuzumab; Device: positron emission tomography; Other: laboratory biomarker analysis; Procedure: Computed Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 20145 Aug 2024

First posted11 Sep 2013 (estimated)
Study start19 Nov 2014
Primary completion30 Mar 2019
Study completion5 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adenocarcinoma of the Gastroesophageal JunctionStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01939275
Sponsor's protocol ID: 13229
Other IDs: NCI-2013-01721, 13229
Status last verified: Feb 2025
First submitted: 6 Sep 2013
Last updated: 28 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms

All Adenocarcinoma of the Gastroesophageal Junction trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 64Cu-DOTA-trastuzumab Positron Emission Tomography in Patients With Gastric Cancer
ClinicalTrials.gov ID: NCT01939275
Acronym / sponsor ID: 13229
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: City of Hope Medical CenterUniversity, hospital or other
Study start: 19 Nov 2014 (actual)
Primary completion: 30 Mar 2019 (actual)
Study completion: 5 Aug 2024 (actual)
First posted: 11 Sep 2013 (estimated)
Results: Posted 8 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)	Experimental	Radiation: copper Cu 64-DOTA-trastuzumab, Device: positron emission tomography, Other: laboratory biomarker analysis, Procedure: Computed TomographyPatients receive copper Cu 64-DOTA-trastuzumab IV on day 1 and then undergo PET/CT scan on days 2 or 3.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
copper Cu 64-DOTA-trastuzumabAlso: 64Cu-DOTA-trastuzumabUndergo Copper Cu 64-DOTA-trastuzumab PET/CT scan	Radiation	Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo Copper Cu 64-DOTA-trastuzumab PET/CT scan	Device	Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
laboratory biomarker analysisCorrelative studies	Other	Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo Copper Cu 64-DOTA-trastuzumab PET/CT scan	Procedure or surgery	Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)

Primary outcome

Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
Time frame: Up to 1 year
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.

Results and safety

Results posted to the registry on 8 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)	8	8

Primary outcome: Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings

Time frame: Up to 1 year. Number. Unit: participants

Measure	Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan) n = 8
HER2 Negative, Tumor Visual Negative	5
HER 2 Positive, Tumor Visual Negative	1
HER 2 Equivocal, Tumor Visual Negative	2
HER2 Negative, Tumor Visual Positive	0
HER 2 Positive, Tumor Visual Positive	0
HER 2 Equivocal, Tumor Visual Positive	0

Adverse events

Time frame: Adverse events were collected over a period of 2 years and 4 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Adenocarcinoma of the Gastroesophageal Junction

RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yanghee Woo, MD principal investigator

City of Hope Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01939275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.