5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors

NCT07589101 | Not Yet Recruiting DMC

• 1 other identifier: 2024YJZ64
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Radiation Dosimetry of 68Ga-MY

  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)

  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)

  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

Study Arms (1)

68Ga-MY PET Imaging

EXPERIMENTAL

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; Drug: 68Ga-MY

Interventions

18F-FDG DRUG

All study participants will undergo one 18F-FDG PET/CT scan.

68Ga-MY PET Imaging

68Ga-MY DRUG

68Ga-MY is an investigational tracer, and all participants will undergo 68Ga-MY scanning.

68Ga-MY PET Imaging

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Hua Zhu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zhu

CONTACT

010-88196495; zhuhuaBCH@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data access will be granted through a secure data sharing agreement for a period of 3 years after publication.
• Access Criteria: Applicants must provide a methodologically sound research plan and obtain approval from their institutional ethics committee.

Locations

CN (1)