Breast Cancer, Lung Cancer
Conditions
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.
Interventions
DRUG18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan.
DRUG68Ga-MY
68Ga-MY is an investigational tracer, and all participants will undergo 68Ga-MY scanning.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dosimetry of 68Ga-MY | 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. |
| Standardized Uptake Value (SUV) | 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. |
| The ratio of Tumor SUV to background SUV (SUVR) | 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. |
Countries
China
Contacts
CONTACTHua Zhu
PRINCIPAL_INVESTIGATORHua Zhu
Peking University Cancer Hospital & Institute
Outcome results
None listed