Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanolattix Biotechnology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
RT01-89Zr
DrugIntravenous injection of RT01-89Zr with a dosage of 1-2 mCi
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: RT01-89ZrExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety evaluation
The number and percentage of patients with adverse events/serious adverse events
Time frame
Within 21 days after administrationSecondary outcomes
1
Biological distribution
Obtain the accumulation (%ID)of each organ of interest through RT01-89Zr PET/CT images
Time frame
through study completion, an average of 3 months2
Radiation Dosimetry
Calculate the radiation-absorbed dose of each organ and lesion and the whole-body effective dose using the MIRD method
Time frame
through study completion, an average of 3 months3
Visual Analysis
Image visual score 0-3 (0 no obvious uptake, 1 slightly above background, 2 above background, 3 significantly above background)
Time frame
through study completion, an average of 3 months4
Semi-quantitative analysis
Standard uptake values (SUVmax, SUVmean)
Time frame
through study completion, an average of 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov