Solid Tumors
Conditions
Brief summary
RT01-89Zr is a TF-targeting radiopharmaceutical diagnostic agent. This trial aims to evaluate the safety, biodistribution, dosimetry, and imaging characteristics of RT01-89Zr as a PET/CT tracer in patients with malignant solid tumors that highly express the TF target.
Interventions
DRUGRT01-89Zr
Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi
Sponsors
Nanolattix Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients of either gender, ages 18-75 (including 18 and 75); * ECOG Performance Status: 0 or 1; * Confirmed as a solid tumor by histopathology or cytology; * At least one primary or metastatic lesion confirmed by conventional imaging； * During the screening period, tumor tissue samples (either archived previously or freshly biopsied) can be provided, with positive target expression of more than 1%; * Voluntarily participate in this study and sign a written informed consent form, agree to comply with the research procedures, and cooperate throughout the entire research process; * Women of childbearing potential must have a negative pregnancy test result. If the patient is of childbearing potential, she must agree to abstain from sexual activity or use highly effective contraception from the time of signing the informed consent until 3 months after the administration of the investigational drug;
Exclusion criteria
* Patients who are unable to complete a PET/CT scan (including those who cannot lie flat, have claustrophobia, or have fear of radiation, etc.); * Those who have received radiopharmaceuticals before administration and whose discontinuation duration does not exceed 5 half-lives; * Participants who have participated in other clinical trials within the past 3 months (except for clinical trials of investigational drugs discontinued for more than 5 half-lives, and assessed by the investigator as having no impact on endpoint evaluation and participant safety), or who plan to participate during the trial; * Acute systemic diseases and electrolyte disorders; * Patients known to be allergic to the RT01 contrast agent or synthetic excipients; * Researchers believe that patients with poor adherence; * Patients who are pregnant or breastfeeding; * Other factors that render the patient unsuitable for trial participation..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | Within 21 days after administration | The number and percentage of patients with adverse events/serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological distribution | through study completion, an average of 3 months | Obtain the accumulation (%ID)of each organ of interest through RT01-89Zr PET/CT images |
| Radiation Dosimetry | through study completion, an average of 3 months | Calculate the radiation-absorbed dose of each organ and lesion and the whole-body effective dose using the MIRD method |
| Visual Analysis | through study completion, an average of 3 months | Image visual score 0-3 (0 no obvious uptake, 1 slightly above background, 2 above background, 3 significantly above background) |
| Semi-quantitative analysis | through study completion, an average of 3 months | Standard uptake values (SUVmax, SUVmean) |
| Probe Targeting Performance Analysis | through study completion, an average of 3 months | The sensitivity (positive rate) of RT01-89Zr PET/CT in patients with solid tumors |
Countries
China
Contacts
CONTACTJingchun Yu
Outcome results
None listed