NCT07593209

Brief Summary

Purpose Ephrin type-A receptor 2 (EphA2) is a receptor tyrosine kinase overexpressed in various solid tumors and associated with tumor progression, metastasis, and poor prognosis. However, noninvasive imaging tools for assessing EphA2 expression in vivo remain limited. This study aims to develop a novel 68Ga-labeled EphA2-targeting positron emission tomography (PET) tracer for specific imaging of EphA2-positive malignancies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
19mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Dec 2027

Study Start

First participant enrolled

May 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

May 7, 2026

Last Update Submit

May 12, 2026

Conditions

Malignant Tumor

Keywords

EphA2

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Treatment-Emergent Adverse Events Following ⁶⁸Ga-NOTA-EphA2

    Number of participants experiencing treatment-emergent adverse events (TEAEs) after administration of ⁶⁸Ga-NOTA-EphA2, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    From tracer administration to 24 hours after tracer injection.

  • Biodistribution of ⁶⁸Ga-NOTA-EphA2 Measured by Standardized Uptake Value (SUV)

    Biodistribution of ⁶⁸Ga-NOTA-EphA2 in normal organs measured by maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on PET/CT imaging.

    From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).

  • Tumor Uptake of ⁶⁸Ga-NOTA-EphA2 on PET/CT

    Tumor uptake of ⁶⁸Ga-NOTA-EphA2 measured by lesion SUVmax, SUVmean, and tumor-to-background ratio on PET/CT imaging.

    From tracer injection to completion of PET/CT imaging (approximately 2-3 hours).

Study Arms (1)

Enrolled patients

Patients with Malignant Tumor

Device: 68Ga- DOTA-EphA2 PET/CT Imaging of Malignant Tumor

Interventions

68Ga- DOTA-EphA2 PET/CT Imaging of Malignant TumorDEVICE

Study of the Radioligand 68Ga- DOTA-EphA2 for PET/CT Imaging of Malignant Tumor

Enrolled patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Malignant Tumor

You may qualify if:

  • Adults aged 18-80 years
  • Patients with suspected or histologically confirmed malignant tumors At least one measurable lesion identified by conventional imaging (CT, MRI, or ultrasound)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Ability to understand the study procedures and provide written informed consent
  • Adequate organ function allowing PET/CT examination

You may not qualify if:

  • Pregnant or breastfeeding women
  • Severe hepatic, renal, cardiovascular, or pulmonary dysfunction considered --unsuitable for PET/CT imaging
  • Known allergy or hypersensitivity to study-related compounds
  • Patients unable to tolerate PET/CT examination or remain still during image acquisition
  • Participation in other investigational drug or radionuclide studies within 4 weeks prior to enrollment
  • Any medical or psychiatric condition judged by the investigators to interfere with study participation or interpretation of imaging results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PET

Shenyang, Liaoning, 110001, China

RECRUITING

Related Publications (1)

  • Zhang MJ, Chen Y, Zhang C, Bian X, Zhang X, Huang S, Yang B, Lu S, Fu X, Zhao W, Kong XD, Zhao S. Development of a 177Lu-labeled EphA2-targeting cyclic peptide combined with an HPK1 inhibitor for synergistic anti-tumor effects. Cell Oncol (Dordr). 2025 Dec;48(6):1757-1774. doi: 10.1007/s13402-025-01105-1. Epub 2025 Oct 2.

    PMID: 41037223BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Postoperative lesion wax block

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Shu Wang, PhD

CONTACT

15040289429shuwang201508@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nuclear Medicine

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 18, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)