Recruiting NCT07505069
Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RT01-89Zr.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug RT01-89Zr
Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi
Primary outcome measures
- Safety evaluation [Time frame: Within 21 days after administration]
Secondary outcome measures (8)
- Biological distribution [Time frame: through study completion, an average of 3 months]
- Radiation Dosimetry [Time frame: through study completion, an average of 3 months]
- Visual Analysis [Time frame: through study completion, an average of 3 months]
- Semi-quantitative analysis [Time frame: through study completion, an average of 3 months]
- Probe Targeting Performance Analysis [Time frame: through study completion, an average of 3 months]
- Biological distribution [Time frame: through study completion, an average of 3 months]
- Biological distribution [Time frame: through study completion, an average of 3 months]
- Semi-quantitative analysis [Time frame: through study completion, an average of 3 months]
Eligibility criteria
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..
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Affiliated Hospital of Jiangnan University — Wuxi
Identifiers
NCT: NCT07505069 · QM-RT01-2551