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NCT Number: NCT07589101

5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zhu

CONTACT

[email protected]

010-88196495

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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