5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University Cancer Hospital & Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with solid tumors;
Presence of measurable lesions on imaging examinations;
Expected survival ≥12 weeks.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
18F-FDG
DrugAll study participants will undergo one 18F-FDG PET/CT scan.
68Ga-MY
Drug68Ga-MY is an investigational tracer, and all participants will undergo 68Ga-MY scanning.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: 68Ga-MY PET ImagingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
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.2
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.
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.3
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.
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 injectionSponsors and contacts
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Source ClinicalTrials.gov
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