5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors

May 8, 2026 updated by: Peking University Cancer Hospital & Institute

Preparation of 5T4 Tumor Novel Target Nanobody PET Probe and Clinical Translation in Lung Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with solid tumors;
  2. Presence of measurable lesions on imaging examinations;
  3. Expected survival ≥12 weeks.

Exclusion Criteria:

  1. Severe hepatic or renal dysfunction;
  2. Women who are planning pregnancy, pregnant, or breastfeeding;
  3. Unable to remain in supine position for 30 minutes;
  4. Refusal to participate in this clinical study;
  5. Diagnosis of claustrophobia or other psychiatric disorders;
  6. Other conditions deemed by the investigator as inappropriate for participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan.
Drug: 68Ga-MY
68Ga-MY is an investigational tracer, and all participants will undergo 68Ga-MY scanning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Radiation Dosimetry Organ-absorbed doses (mGy/MBq) and effective dose (mSv/MBq) calculated from PET/CT data using OLINDA/EXM software based on the MIRD schema. Organs assessed include, but are not limited to, the liver, spleen, kidneys, lungs, heart, bone marrow, and urinary bladder.
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.
Standardized Uptake Value (SUV)
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.
Parameters of SUV The maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean) and tumor/background ratio (SUVR) of 68Ga-MY in target lesions were observed. SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue.
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.
The ratio of Tumor SUV to background SUV (SUVR)
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
SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Hua Zhu, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024YJZ64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with the ICMJE data-sharing guidelines and Chinese data-privacy laws, raw clinical and imaging data were not publicly available to prevent compromise of patient privacy. However, the corresponding author will share deidentified patient-level data, imaging parameters (SUV values), and study protocol details if reasonably requested by the requestor.

IPD Sharing Time Frame

Data access will be granted through a secure data sharing agreement for a period of 3 years after publication.

IPD Sharing Access Criteria

Applicants must provide a methodologically sound research plan and obtain approval from their institutional ethics committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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