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NCT Number: NCT07505069

Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214122, China

Location status: Recruiting

Location contact

Jingchun Yu

CONTACT

[email protected]

0510-68089404

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

RT01-89Zr

Drug

Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi

Primary outcomes

  1. Safety evaluation

    Time frame: Within 21 days after administration

    The number and percentage of patients with adverse events/serious adverse events

Secondary outcomes

  1. Biological distribution

    Time frame: through study completion, an average of 3 months

    Obtain the accumulation (%ID)of each organ of interest through RT01-89Zr PET/CT images

  2. Radiation Dosimetry

    Time frame: 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

  3. Visual Analysis

    Time frame: 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)

  4. Semi-quantitative analysis

    Time frame: through study completion, an average of 3 months

    Standard uptake values (SUVmax, SUVmean)

  5. Probe Targeting Performance Analysis

    Time frame: through study completion, an average of 3 months

    The sensitivity (positive rate) of RT01-89Zr PET/CT in patients with solid tumors

  6. Biological distribution

    Time frame: through study completion, an average of 3 months

    Retention time of each organ of interest through RT01-89Zr PET/CT images

  7. Biological distribution

    Time frame: through study completion, an average of 3 months

    Standard uptake value(SUV) of each organ of interest through RT01-89Zr PET/CT images

  8. Semi-quantitative analysis

    Time frame: through study completion, an average of 3 months

    Target-to-background ratio (TBR) (background can include mediastinum, general background, liver, muscle);

Study contacts

Contact information is provided by the study sponsor or research team.

Jingchun Yu

CONTACT

[email protected]

0510-68089404

Sponsors and collaborators

Lead sponsor

Nanolattix Biotechnology Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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