5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07589101
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 18F-FDG — DRUG
    All study participants will undergo one 18F-FDG PET/CT scan.
  • 68Ga-MY — DRUG
    68Ga-MY is an investigational tracer, and all participants will undergo 68Ga-MY scanning.

Study Details

This study aims to evaluate a novel 5T4 targeted nanobody PET imaging tracer, 68Ga-MY, for the detection and evaluation of solid tumors. The 5T4 oncofoetal antigen is considered a valuable tumor-associated antigen, which is expressed in many different cancers, but is rarely expressed in normal adult tissues. And cell surface expression of 5T4 is an important property for antibody-targeted therapies. It has been shown that 5T4 is expressed on tumour-initiating cells (TICs) and associated with worse clinical outcome. Moreover, decreased adherence due to 5T4 expression may be associated with cancer spread. In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-MY. The imaging results will be compared with 18F-FDG. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-MY PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.

Key Dates

First listed
May 15, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 68Ga-MY PET Imaging
    All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-MY PET/CT scans.After the participant rests quietly for 40 minutes or 1 hour, whole-body imaging of the head and torso will be performed using a United Imaging uEXPLORER Whole-Body PET/CT scanner at 1 h, 2 h, and 3 h post-injection. The scan range will cover from the vertex to the upper third of the thighs. Participants who required a dynamic scan underwent a 40-min serial scan after injection of 68Ga-MY. PET/CT static imaging was performed at 2 h and 3 h after injection.

Primary Outcome Measure

Radiation Dosimetry of 68Ga-MY [ Time Frame: 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection. ]

Central Contacts

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