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First Human Trial of Targeting MDM2/MDMX PET Imaging

NCT06443762 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-05-31

No results posted yet for this study

Summary

Investigation of the Radiotracer Uptake of \[68Ga\] MDM2/MDMX Peptide at Lesion Sites in Patients with Malignant Tumors, and Evaluation of the Capability of \[68Ga\] MDM2/MDMX Peptide to Detect Overexpression of MDM2/MDMX in Tumor Patients, Particularly Those with Recurrent or Advanced Disease.

Conditions

  • MDM2/MDMX Gene Mutation
  • Nuclear Medicine
  • Positron Emission Tomography Imaing

Interventions

DRUG

[68Ga] MDM2/MDMX Peptide

Utilizing a peptide with high affinity to MDM2/MDMX as the targeting moiety for radiopharmaceuticals, this study explores the diagnostic efficacy of \[68Ga\] MDM2/MDMX Peptide in patients with malignant tumors exhibiting high MDM2/MDMX expression. This approach not only provides a basis for the early diagnosis of malignant tumors but also facilitates the formulation of effective precision therapy strategies tailored to the tumor's MDM2/MDMX expression profile, particularly for patients with recurrent and metastatic disease. \[68Ga\] MDM2/MDMX Peptide, a novel MDM2/MDMX-targeted molecular probe labeled with 68Ga, utilizes DOTA as a bifunctional chelator for complexing with 68Ga3+. The labeling process is straightforward, allowing for direct use without purification, and demonstrates high in vivo stability.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-03
Primary Completion
2025-05-01
Completion
2025-05-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443762 on ClinicalTrials.gov