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NCT01939275

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

Completed NA Results posted Last updated 28 February 2025
What this trial tests

NA trial testing copper Cu 64-DOTA-trastuzumab in Adenocarcinoma of the Gastroesophageal Junction in 8 participants. Completed in 5 August 2024.

Timeline
19 November 2014
Primary endpoint
30 March 2019
5 August 2024

Quick facts

Lead sponsorCity of Hope Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment8
Start date19 November 2014
Primary completion30 March 2019
Estimated completion5 August 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

City of Hope Medical Center

Who can join

18 and older, any sex, with Adenocarcinoma of the Gastroesophageal Junction or Diffuse Adenocarcinoma of the Stomach. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings Primary · 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.

HER2 Negative, Tumor Visual Negative
GroupValue95% CI
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)5
HER 2 Positive, Tumor Visual Negative
GroupValue95% CI
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)1
HER 2 Equivocal, Tumor Visual Negative
GroupValue95% CI
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)2
HER2 Negative, Tumor Visual Positive
GroupValue95% CI
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)0
HER 2 Positive, Tumor Visual Positive
GroupValue95% CI
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)0
HER 2 Equivocal, Tumor Visual Positive
GroupValue95% CI
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over a period of 2 years and 4 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Serious: 0/8 (0%)
Deaths: 0/8
Other adverse events (27 terms — click to expand)

ReactionSystemDiagnostic (Copper Cu 64-D…
AnemiaBlood and lymphatic system disorders
HypoalbuminemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
HypophosphatemiaMetabolism and nutrition disorders
Blood bilirubin increasedInvestigations
HypocalcemiaMetabolism and nutrition disorders
Sinus tachycardiaCardiac disorders
Abdominal distensionGastrointestinal disorders
Abdominal painGastrointestinal disorders
DiarrheaGastrointestinal disorders
ChillsGeneral disorders
Edema limbsGeneral disorders
FatigueGeneral disorders
BruisingInjury, poisoning and procedural complications
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Platelet count decreasedInvestigations
Weight lossInvestigations
AcidosisMetabolism and nutrition disorders
AnorexiaMetabolism and nutrition disorders
HypercalcemiaMetabolism and nutrition disorders
HypokalemiaMetabolism and nutrition disorders
HeadacheNervous system disorders
SomnolenceNervous system disorders
Sore throatRespiratory, thoracic and mediastinal disorders
TachypneaRespiratory, thoracic and mediastinal disorders
HypertensionVascular disorders

Data from ClinicalTrials.gov NCT01939275 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Harnessing Integrative Omics to Facilitate Molecular Imaging of the Human Epidermal Growth Factor Receptor Family for Precision Medicine.
    Pool M, de Boer HR, Hooge MNL, van Vugt MATM, et al · · 2017 · cited 10× · PMID 28638489 · DOI 10.7150/thno.17934
  2. ImmunoPET Targeting Receptor Tyrosine Kinase: Clinical Applications.
    Linguanti F, Abenavoli EM, Calabretta R, Berti V, et al · · 2023 · cited 2× · PMID 38136430 · DOI 10.3390/cancers15245886
  3. <i>CopperNostics</i>-Here We Are Now, Entertain Us!
    Brühlmann SA, Walther M, Kopka K, Kreller M, et al · · 2026 · PMID 41754861 · DOI 10.3390/ph19020321

Verify or expand the search:

Other trials of copper Cu 64-DOTA-trastuzumab

Trials testing the same drug.

Other recruiting trials for Adenocarcinoma of the Gastroesophageal Junction

Currently open trials in the same condition.

Other City of Hope Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01939275.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing