Sub-topic Four: Clinical Translation of Original Radioactive Drugs for Precision Diagnosis and Treatment of Gastrointestinal Tumors -Clinical Application Value of PET Imaging Targeting LRRC15 in Malignant Tumors

April 20, 2026 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This project utilizes LRRC15-specific targeted PET radiotracers to perform PET/MR or PET/CT imaging on healthy volunteers and patients with clinically suspected or confirmed malignancies characterized by high LRRC15 expression-including pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma. The study aims to achieve the following objectives:

For patients with malignant tumors: To diagnose and stage the disease. By comparing the imaging results against the gold standard of histopathological diagnosis, the study aims to evaluate diagnostic efficacy, ascertain the presence or absence of lesions, and characterize their anatomical location and nature. Furthermore, through comparison with [¹⁸F]FDG PET or [⁶⁸Ga]Ga-FAPI PET, the study seeks to achieve accurate disease staging, assess tumor burden, and facilitate therapeutic decision-making.

For healthy volunteers: To conduct pharmacokinetic analyses to determine the in vivo biodistribution and metabolic patterns of the radiotracer, as well as to evaluate its safety profile.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Wuhan Union Hospital, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with clinically suspected or confirmed malignancies-such as pancreatic cancer, breast cancer, lung cancer, sarcoma, head and neck tumors, glioblastoma, colorectal cancer, and melanoma (supported by evidence including serum tumor markers, ultrasound, CT, MRI, and tissue histopathological examinations)-who are in good general condition.

Description

Inclusion Criteria:

Each subject must meet all of the following inclusion criteria to be eligible for study enrollment:

  1. The subject or their legally authorized representative (LAR) is capable of providing a signed and dated informed consent form (ICF);
  2. Willing and able to comply with all study procedures and cooperate throughout the entire duration of the study;
  3. Adult patients or healthy volunteers, aged 18 years or older, male or female;
  4. Patients with clinically suspected or confirmed malignancies (supported by evidence such as relevant serum tumor markers, imaging modalities including ultrasound, CT, and MRI, or histopathological examinations) who are in good general condition;
  5. Women of childbearing potential (WOCBP) must have used effective contraception for at least one month prior to screening and agree to continue contraceptive use throughout the study period and for a specified duration following study completion;
  6. Must meet any other protocol-specified inclusion criteria.

Exclusion Criteria:

Any subject meeting any of the following baseline criteria will be excluded from the study:

  1. Inability to tolerate or complete PET/MR or PET/CT examinations (including, but not limited to, the inability to lie supine, claustrophobia, radiophobia, etc.);
  2. Presence of other comorbidities, such as acute systemic illnesses and electrolyte imbalances;
  3. Known allergy or hypersensitivity to the LRRC15 radiotracer or its synthetic excipients; fasting blood glucose level exceeding 11.0 mmol/L prior to [¹⁸F]FDG injection;
  4. Patients deemed by the investigator to have poor expected compliance;
  5. Pregnant or lactating (nursing) women;
  6. Presence of any other conditions or factors that, in the opinion of the investigator, would make the subject unsuitable for participation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual and standardized uptake values assessment of lesions and biodistribution
Time Frame: 1 year
At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of the tumor and organs will be measured after a semiquantitative analysis is performed for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting LRRC15 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or a higher stage.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xiaoli Lan, PhD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XLan-260401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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